Registration & testing

Certificates you can open and read.

Scan-quality copies of every registration certificate issued for the devices produced on our lines, plus the covers of the type-test reports on file. Originals are in Chinese; English translations are provided for reference. Full PDFs open from each thumbnail.

Registration & testing

Registration certificates & test reports.

Six registration certificates — Chinese originals with English translations where available — plus the covers of the type-test reports on file. Click any certificate or its title to open the full copy below.

Registration certificates — full copies

Every page, as issued.

Microwave ablation generator NMPA registration certificate (original, Chinese) Open PDF ↗

NMPA registration · original (Chinese)

Microwave ablation generator

Certificate No.
国械注准 20253010197
Device class
Class III (China) · active device
Issuing authority
National Medical Products Administration
Valid until
19 January 2030
Microwave ablation generator registration certificate, page 1
Page 1 of 1
Microwave ablation generator NMPA registration certificate, English translation Open PDF ↗

NMPA registration · English translation

Microwave ablation generator — translation

Certificate No.
国械注准 20253010197
Status
English translation for reference; original certificate prevails
Microwave ablation generator registration certificate, English translation, page 1
Page 1 of 2
Microwave ablation generator registration certificate, English translation, page 2
Page 2 of 2
Single-use microwave ablation needle NMPA registration certificate (original, Chinese) Open PDF ↗

NMPA registration · original (Chinese)

Single-use microwave ablation needle

Certificate No.
国械注准 20253010071
Device class
Class III (China) · sterile single-use device
Issuing authority
National Medical Products Administration
Valid until
9 January 2030
Registered indications
Solid liver tumours; benign thyroid nodules
Single-use microwave ablation needle registration certificate, page 1
Page 1 of 2
Single-use microwave ablation needle registration certificate, page 2
Page 2 of 2
Single-use microwave ablation needle NMPA registration certificate, English translation Open PDF ↗

NMPA registration · English translation

Single-use microwave ablation needle — translation

Certificate No.
国械注准 20253010071
Status
English translation for reference; original certificate prevails
Single-use microwave ablation needle registration certificate, English translation, page 1
Page 1 of 3
Single-use microwave ablation needle registration certificate, English translation, page 2
Page 2 of 3
Single-use microwave ablation needle registration certificate, English translation, page 3
Page 3 of 3
Lung nodule localization needle registration certificate (original, Chinese) Open PDF ↗

Provincial registration · original (Chinese)

Single-use lung nodule localization needle

Certificate No.
苏械注准 20242021492
Device class
Class II (China) · sterile single-use device
Issuing authority
Jiangsu Provincial Medical Products Administration
Valid until
14 July 2029
Lung nodule localization needle registration certificate, page 1
Page 1 of 2
Lung nodule localization needle registration certificate, page 2
Page 2 of 2
Disposable radiofrequency ablation electrode registration certificate (original, Chinese) Open PDF ↗

Provincial registration · original (Chinese)

Disposable radiofrequency ablation electrode

Certificate No.
赣械注准 20242010142
Device class
Sterile single-use device
Issuing authority
Jiangxi Provincial Medical Products Administration
Date of issue
9 July 2024
Valid until
8 July 2029
Disposable radiofrequency ablation electrode registration certificate, page 1
Page 1 of 1
Disposable radiofrequency ablation electrode registration certificate, English translation Open PDF ↗

Provincial registration · English translation

Disposable radiofrequency ablation electrode — translation

Certificate No.
赣械注准 20242010142 (Jiangxi Province, China)
Status
English translation for reference; original certificate prevails
Disposable radiofrequency ablation electrode registration certificate, English translation, page 1
Page 1 of 2
Disposable radiofrequency ablation electrode registration certificate, English translation, page 2
Page 2 of 2
Venous stripping catheter registration certificate (original, Chinese) Open PDF ↗

Provincial registration · original (Chinese)

Venous stripping catheter

Certificate No.
赣械注准 20242020151
Device class
Sterile single-use device
Issuing authority
Jiangxi Provincial Medical Products Administration
Date of issue
17 July 2024
Valid until
16 July 2029
Intended use
Stripping of varicose veins in great saphenous vein surgery
Venous stripping catheter registration certificate, page 1
Page 1 of 1
Single-use puncture needle registration certificate (original, Chinese) Open PDF ↗

Provincial registration · original (Chinese)

Single-use puncture needle

Certificate No.
浙械注准 20252142036
Model
BN-MAR-1
Device class
Class II (China) · sterile single-use device
Issuing authority
Zhejiang Provincial Medical Products Administration
Date of issue
31 December 2025
Valid until
30 December 2030
Intended use
Puncture of human tissue (excluding lumbar spine, blood vessels and brain ventricles) for sample collection, or as an access channel for other instruments
Single-use puncture needle registration certificate, page 1
Page 1 of 9 · registration certificate
Single-use puncture needle product technical requirements, page 2
Page 2 of 9 · product technical requirements
Single-use puncture needle product technical requirements, page 3
Page 3 of 9 · product technical requirements
Single-use puncture needle product technical requirements, page 4
Page 4 of 9 · product technical requirements
Single-use puncture needle product technical requirements, page 5
Page 5 of 9 · product technical requirements
Single-use puncture needle product technical requirements, page 6
Page 6 of 9 · product technical requirements
Single-use puncture needle product technical requirements, page 7
Page 7 of 9 · product technical requirements
Single-use puncture needle product technical requirements, page 8
Page 8 of 9 · product technical requirements
Single-use puncture needle product technical requirements, page 9
Page 9 of 9 · product technical requirements
Type-test report cover pages for microwave ablation generator and needle Open PDF ↗

Type testing · report cover pages

Generator & needle type-test reports

Scope
Electrical safety, EMC and microwave performance testing of the ablation generator and ablation needle
Availability
Full reports on request, under NDA
Type-test report 2023-WT-1269-AF, LG-MWS-11A generator, performance test
Page 1 of 10 · LG-MWS-11A generator — performance test · Report 2023-WT-1269-AF
Type-test report 2023-WT-1269-EF, LG-MWS-11A generator, EMC test
Page 2 of 10 · LG-MWS-11A generator — EMC test · Report 2023-WT-1269-EF
Type-test report 2023-WT-1270-AF, LG-MWS-10A generator, performance test
Page 3 of 10 · LG-MWS-10A generator — performance test · Report 2023-WT-1270-AF
Type-test report 2023-WT-1270-EF, LG-MWS-10A generator, EMC test
Page 4 of 10 · LG-MWS-10A generator — EMC test · Report 2023-WT-1270-EF
Type-test report 2023-WT-2009-AF, LG-MWA-03B needle, performance test
Page 5 of 10 · LG-MWA-03B needle — performance test · Report 2023-WT-2009-AF
Type-test report 2023-WT-2009-EF, LG-MWA-03B needle, EMC test
Page 6 of 10 · LG-MWA-03B needle — EMC test · Report 2023-WT-2009-EF
Biological evaluation report STI-20230822-035SC2-2, LG-MWA-03B needle
Page 7 of 10 · LG-MWA-03B needle — biological evaluation · Report STI-20230822-035SC2-2
Type-test report 2023-WT-2008-AF, LG-MWB-02B needle, performance test
Page 8 of 10 · LG-MWB-02B needle — performance test · Report 2023-WT-2008-AF
Type-test report 2023-WT-2008-EF, LG-MWB-02B needle, EMC test
Page 9 of 10 · LG-MWB-02B needle — EMC test · Report 2023-WT-2008-EF
Biological evaluation report STI-20230822-035SC2-1, LG-MWB-02B needle
Page 10 of 10 · LG-MWB-02B needle — biological evaluation · Report STI-20230822-035SC2-1

Patents & software copyrights — full copies

Every certificate, as issued.

Portable microwave ablation embedded system software Open PDF ↗

Software copyright · China Copyright Protection Centre

Portable microwave ablation embedded system software

Registration No.
2024SR0288147
Certificate No.
软著登字第 12692020 号
Version
V1.0
Registered
21 February 2024
Portable microwave ablation embedded system software, page 1
Page 1 of 1
Vertical microwave ablation display & control software Open PDF ↗

Software copyright · China Copyright Protection Centre

Vertical microwave ablation display & control software

Registration No.
2024SR0289117
Certificate No.
软著登字第 12692990 号
Version
V1.0
Registered
21 February 2024
Vertical microwave ablation display & control software, page 1
Page 1 of 1
Vertical microwave ablation embedded system software Open PDF ↗

Software copyright · China Copyright Protection Centre

Vertical microwave ablation embedded system software

Registration No.
2024SR0290590
Certificate No.
软著登字第 12694463 号
Version
V1.0
Registered
21 February 2024
Vertical microwave ablation embedded system software, page 1
Page 1 of 1
Vertical microwave intelligent ablation sensing & communication system Open PDF ↗

Software copyright · China Copyright Protection Centre

Vertical microwave intelligent ablation sensing & communication system

Registration No.
2024SR0492379
Certificate No.
软著登字第 12896252 号
Version
V1.0
Registered
11 April 2024
Vertical microwave intelligent ablation sensing & communication system, page 1
Page 1 of 1
Water-cooled curved-handle microwave ablation needle Open PDF ↗

Design patent · CNIPA

Water-cooled curved-handle microwave ablation needle

Patent No.
ZL 2023 3 0429374.5
Certificate No.
第 8462108 号
Granted
26 January 2024
Issuing authority
China National Intellectual Property Administration
Water-cooled curved-handle microwave ablation needle, page 1
Page 1 of 2 · certificate
Water-cooled curved-handle microwave ablation needle, page 2
Page 2 of 2 · design photographs
Water-cooled straight-handle microwave ablation needle Open PDF ↗

Design patent · CNIPA

Water-cooled straight-handle microwave ablation needle

Patent No.
ZL 2023 3 0429373.0
Certificate No.
第 8477676 号
Granted
6 February 2024
Issuing authority
China National Intellectual Property Administration
Water-cooled straight-handle microwave ablation needle, page 1
Page 1 of 2 · certificate
Water-cooled straight-handle microwave ablation needle, page 2
Page 2 of 2 · design photographs
Needle-angle assist device for CT-guided microwave ablation Open PDF ↗

Utility model patent · CNIPA

Needle-angle assist device for CT-guided microwave ablation

Patent No.
ZL 2023 2 2403447.0
Granted
13 August 2024
Issuing authority
China National Intellectual Property Administration
Needle-angle assist device for CT-guided microwave ablation, page 1
Page 1 of 1
Repositionable breast localization device Open PDF ↗

Utility model patent · CNIPA

Repositionable breast localization device

Patent No.
ZL 2024 2 3128218.3
Granted
16 January 2026
Issuing authority
China National Intellectual Property Administration
Repositionable breast localization device, page 1
Page 1 of 1
Lung nodule localization device with puncture guide needle Open PDF ↗

Utility model patent · CNIPA

Lung nodule localization device with puncture guide needle

Patent No.
ZL 2024 2 3104820.3
Granted
30 January 2026
Issuing authority
China National Intellectual Property Administration
Lung nodule localization device with puncture guide needle, page 1
Page 1 of 1
Scaffold-style protective sheath for microwave ablation needles Open PDF ↗

Utility model patent · CNIPA

Scaffold-style protective sheath for microwave ablation needles

Patent No.
ZL 2023 2 2403331.7
Granted
13 August 2024
Issuing authority
China National Intellectual Property Administration
Scaffold-style protective sheath for microwave ablation needles, page 1
Page 1 of 1
Balloon occlusion catheter Open PDF ↗

Utility model patent · CNIPA

Balloon occlusion catheter

Patent No.
ZL 2024 2 0029596.7
Granted
13 September 2024
Issuing authority
China National Intellectual Property Administration
Balloon occlusion catheter, page 1
Page 1 of 1
Lung nodule puncture localization device Open PDF ↗

Utility model patent · CNIPA

Lung nodule puncture localization device

Patent No.
ZL 2023 2 2403487.5
Granted
30 August 2024
Issuing authority
China National Intellectual Property Administration
Lung nodule puncture localization device, page 1
Page 1 of 1
Patient posture monitoring device for lung surgery Open PDF ↗

Utility model patent · CNIPA

Patient posture monitoring device for lung surgery

Patent No.
ZL 2023 2 2403434.3
Granted
13 August 2024
Issuing authority
China National Intellectual Property Administration
Patient posture monitoring device for lung surgery, page 1
Page 1 of 1
Anti-pneumothorax puncture assist device Open PDF ↗

Utility model patent · CNIPA

Anti-pneumothorax puncture assist device

Patent No.
ZL 2023 2 2403430.5
Granted
13 September 2024
Issuing authority
China National Intellectual Property Administration
Anti-pneumothorax puncture assist device, page 1
Page 1 of 1
Guide structure for venous strippers Open PDF ↗

Utility model patent · CNIPA

Guide structure for venous strippers

Patent No.
ZL 2024 2 2165090.1
Granted
23 September 2025
Issuing authority
China National Intellectual Property Administration
Guide structure for venous strippers, page 1
Page 1 of 1
Water-cooled adjustable ablation electrode Open PDF ↗

Utility model patent · CNIPA

Water-cooled adjustable ablation electrode

Patent No.
ZL 2024 2 0338315.6
Granted
18 February 2025
Issuing authority
China National Intellectual Property Administration
Water-cooled adjustable ablation electrode, page 1
Page 1 of 1
Introducer tip for venous strippers Open PDF ↗

Utility model patent · CNIPA

Introducer tip for venous strippers

Patent No.
ZL 2024 2 0338317.5
Granted
18 February 2025
Issuing authority
China National Intellectual Property Administration
Introducer tip for venous strippers, page 1
Page 1 of 1
Regulatory note: these certificates are the approvals held for the devices produced on our lines in China. Market access in the EU, USA or other regulated territories requires the applicable local approval; we do not claim approvals we do not hold.