Product catalogue
Six registrations. One production platform.
Microwave ablation generators and needles, ablation catheters, localization and access needles, RF ablation electrodes — every specification below is taken from the registered technical file, not from a catalogue wish list.
Registration status
In production, under registration.
Each product is manufactured here under contract for its marketing authorisation holder; certificates remain with the registrant. Production under your own registration is available on the same lines.
| Product | Registration No. | Device type | Valid until | Status |
|---|---|---|---|---|
| Single-use microwave ablation needle | 国械注准20253010071 | Sterile, Class III | 2030-01-09 | Contract production |
| Microwave ablation generator | 国械注准20253010197 | Active, Class III | 2030-01-19 | Contract production |
| Single-use lung nodule localization needle | 苏械注准20242021492 | Sterile, Class II | 2029-07-14 | Contract production |
| Single-use radiofrequency ablation electrode | 赣械注准20242010142 | Sterile | 2029-07-08 | Contract production |
| Venous stripping catheter | 赣械注准20242020151 | Sterile, Class II | 2029-07-16 | Registered |
| Single-use puncture needle | 浙械注准20252142036 | Sterile, Class II | 2030-12-30 | Contract production |
Microwave ablation generator · 国械注准20253010197
Console and antenna, one matched system.
A 2,450 MHz platform paired with internally cooled single-use antennas. The console identifies the connected needle and loads its registered working mode automatically — the energy profile always matches the device in use.
- Automatic needle recognition — no manual mode selection
- Dual-CPU architecture — parallel hardware and software control channels; the standby channel takes over on failure
- Three-channel tissue temperature monitoring with automatic over-temperature protection
- Dual foot pedals on independent control circuits
- Procedure software — retrievable ablation records, editable case reports, cumulative time and cycle logs
- Models LG-MWS-10A/B/C and LG-MWS-11A/B/C, software release V1
Portable platform
The same platform, in portable form.
The portable configuration carries the 2,450 MHz delivery and monitoring architecture into outpatient rooms, smaller theatres and bedside procedures.
- Independent power, time and temperature control
- Compact desktop footprint
- Foot-pedal activation with redundant control circuits
- Compatible with the full single-use antenna portfolio
Capacity · 200 units a year
Core component assembly, system commissioning and burn-in on site. Custom housings and user interfaces available for contract customers.
72 hours per unit
Every generator completes a 72-hour continuous-operation test before release. Field repair rate below 0.5%.
Single-use microwave ablation needle · 国械注准20253010071
Three shaft lengths. Straight or curved. Eighteen registered configurations.
Effective shaft length 130, 170 or 200 mm; tip length 7 or 12 mm; shaft diameter 1.6 or 1.9 mm. Every combination of handle, cable and positioning rings is a separately registered configuration — 18 in total, tolerances as registered.
130 mm shaft
Short working length for superficial nodules and shallow approaches. Max 50 W.
170 mm shaft
General-purpose length for the majority of hepatic and thyroid procedures. Max 70 W.
200 mm shaft
Extended reach for deep lesions and difficult access paths. Max 70 W.
Complete antenna family
Straight and curved handles, with or without output cable, one or two positioning rings — consistent handling across every length. Dimensional tolerance held within 0.05 mm.
Sterile single-use kits
Peel pouch, sterile barrier and carton configurable to your private label. 24-month shelf life from sterilisation.
Process control
Puncture-depth control and biocompatible coating adhesion resolved in process validation; dimensional tolerance held within 0.05 mm.
Eight proposals, 12% cheaper
Eight process-optimisation proposals delivered on live programmes, reducing unit cost by 12% on average.
Single-use microwave ablation catheter
Flexible reach beyond the needle track.
Two catheter series for lesions that cannot be treated from a straight percutaneous track. Model list and dimensional drawings available on request.
Microwave catheter — series A
Flexible shaft access with graduated depth markings for controlled positioning.
Microwave catheter — series B
Alternative handle and shaft geometry for distinct anatomical access requirements.
“Precision in energy delivery; restraint in what we claim.”
Access & localization
Reaching the lesion. Marking it. Keeping it visible.
The lung nodule localization needle (苏械注准20242021492) is registered and produced here in volume; the puncture needle (浙械注准20252142036) serves the same procedures as the access channel.
Disposable puncture needle
Echogenic tip ring, multi-bevel tip and clear hub for sample return — coaxial access for biopsy, drainage and instrument introduction.
Localization needle — anchor
Four claws open inside the nodule and hold position while the lung is deflated, keeping the target identifiable during VATS.
Localization needle — coil
Non-directional coil opens without cutting tissue, lowering puncture-site bleeding risk. Radiopaque from tip to shaft.
End-to-end scope
From raw-material sourcing and core-component assembly to finished-product inspection, built to the customer’s specification and registration.
CT-guided marking, surgery within 24 hours
CT-guided marking of sub-solid and small peripheral nodules before VATS. The damped handle deploys the anchor in one controlled push.
Radiofrequency ablation electrodes · 赣械注准20242010142
Adjustable RF ablation electrodes, registered and in production.
Single-use water-cooled adjustable electrodes, manufactured under contract for the marketing authorisation holder. Registration issued by the Jiangxi Provincial Medical Products Administration on 9 July 2024, valid until 8 July 2029; intended use covers ablation and coagulation of liver, lung, kidney, gallbladder, spleen, thyroid, breast, uterine adnexal and lower-limb venous tissue in non-endoscopic surgery.
- Adjustable, expandable electrode tip
- Tissue-impedance recognition for controlled delivery
- Intended for use with electrosurgical generators in the 200–750 kHz range
- Infusion-compatible electrode with circulating water line for controlled thermal dosing
Full registration certificate, technical requirements and evaluation samples are available on request. Market access outside China requires the applicable local approval.
Specifications
Registered parameters. As filed, as tested.
Values are taken from the approved technical requirements and the registration file. Tolerances are as registered.
Single-use microwave ablation needle — dimensions
- Needle tip length (L1)
- 7 mm or 12 mm ±2
- Tip outer diameter (Φ1)
- 1.6 mm or 1.9 mm
- Effective shaft length (L2)
- 130 / 170 / 200 mm
- Shaft outer diameter (Φ2)
- 1.6 mm or 1.9 mm
- Scale interval
- 10 mm ±1.5
- Tip to first scale line
- 30 mm ±1.5
- Output cable length (where supplied)
- 2.0 m ±0.1
- Operating frequency
- 2,450 MHz ±50
- Maximum power
- 50 W / 70 W
Mechanical and microwave performance
- Puncture force
- ≤ 3 N
- Rigidity (deflection)
- ≤ 30 mm
- Tip connection strength
- ≥ 10 N tensile
- Cooling water flow
- ≥ 33.4 mL/min
- Cooling circuit pressure
- 0.4 MPa / 1 min, no leakage
- Cable insertion loss
- ≤ 18 %/m (0.72 dB/m)
- Cable VSWR
- ≤ 1.5 @ 2,450 MHz
- Needle VSWR
- ≤ 3.0 @ 2,450 MHz
- Shaft temperature sensing
- 10–45 °C, ±1.5 °C
Materials, sterilisation and shelf life
- Needle tip / shaft
- 06Cr19Ni10 (304 SS)
- Dielectric spacer
- PTFE
- Handle, cooling tubes
- Medical-grade polymer
- Output cable
- Shielded low-loss, medical connectors
- Sterilisation
- Ethylene oxide (EO)
- EO residual
- ≤ 10 µg/g
- Shelf life
- 24 months from sterilisation
- Single use
- Sterile, non-pyrogenic, do not resterilise
Chemical and safety classification
- Heavy metals
- ≤ 5 µg/mL
- Oxidisable substances
- ≤ 2.0 mL KMnO₄ 0.01 mol/L
- pH difference vs blank
- ≤ 2.0
- Evaporation residue
- ≤ 5.0 mg
- Applied part
- BF type
- Operating mode
- Continuous, under normal use
- Defibrillation protection
- No claim made
Microwave ablation needle — 18 registered configurations
| No. | Model | Handle | Tip L1 | Tip Ø | Shaft L2 | Shaft Ø | Cable | Rings | Max power |
|---|---|---|---|---|---|---|---|---|---|
| 1 | LG-MWA-01A | Straight | 12 | 1.9 | 200 | 1.9 | No | 1 | 70 W |
| 2 | LG-MWB-02A | Curved | 12 | 1.9 | 200 | 1.9 | No | 1 | 70 W |
| 3 | LG-MWA-03A | Straight | 7 | 1.6 | 130 | 1.6 | No | 1 | 50 W |
| 4 | LG-MWB-04A | Curved | 12 | 1.9 | 130 | 1.9 | No | 1 | 70 W |
| 5 | LG-MWA-05A | Straight | 7 | 1.9 | 170 | 1.9 | No | 1 | 70 W |
| 6 | LG-MWB-06A | Curved | 7 | 1.9 | 170 | 1.9 | No | 1 | 70 W |
| 7 | LG-MWA-01B | Straight | 12 | 1.9 | 200 | 1.9 | Yes | 1 | 70 W |
| 8 | LG-MWB-02B | Curved | 12 | 1.9 | 200 | 1.9 | Yes | 1 | 70 W |
| 9 | LG-MWA-03B | Straight | 7 | 1.6 | 130 | 1.6 | Yes | 1 | 50 W |
| 10 | LG-MWB-04B | Curved | 12 | 1.9 | 130 | 1.9 | Yes | 1 | 70 W |
| 11 | LG-MWA-05B | Straight | 7 | 1.9 | 170 | 1.9 | Yes | 1 | 70 W |
| 12 | LG-MWB-06B | Curved | 7 | 1.9 | 170 | 1.9 | Yes | 1 | 70 W |
| 13 | LG-MWA-01D | Straight | 12 | 1.9 | 200 | 1.9 | No | 2 | 70 W |
| 14 | LG-MWB-02D | Curved | 12 | 1.9 | 200 | 1.9 | No | 2 | 70 W |
| 15 | LG-MWA-03D | Straight | 7 | 1.6 | 130 | 1.6 | No | 2 | 50 W |
| 16 | LG-MWB-04D | Curved | 12 | 1.9 | 130 | 1.9 | No | 2 | 70 W |
| 17 | LG-MWA-05D | Straight | 7 | 1.9 | 170 | 1.9 | No | 2 | 70 W |
| 18 | LG-MWB-06D | Curved | 7 | 1.9 | 170 | 1.9 | No | 2 | 70 W |
Registration & testing
Documentation you can verify.
Registration numbers, standards and report numbers are given as issued, so your regulatory team can verify them before a single unit ships.
国械注准 20253010197
Generator · EN
国械注准 20253010071
Needle · EN
苏械注准 20242021492
赣械注准 20242010142
RF electrode · EN
赣械注准 20242020151
浙械注准 20252142036
Type-test reports
国械注准 20253010197
Generator · EN
国械注准 20253010071
Needle · EN
苏械注准 20242021492
赣械注准 20242010142
RF electrode · EN
赣械注准 20242020151
浙械注准 20252142036
Type-test reports
View all certificates & test reports
NMPA registration — microwave ablation needle
- Certificate number
- 国械注准 20253010071
- Device class
- Class III (China)
- Product name
- Single-use microwave ablation needle
- Date of issue
- 10 January 2025
- Valid until
- 09 January 2030
- Registered indications
- Solid liver tumours; benign thyroid nodules
- Compatible generators
- LG-MWS-10A/B/C, LG-MWS-11A/B/C
Other registrations on the lines
- Microwave ablation generator
- 国械注准 20253010197
- Valid until
- 19 January 2030
- Lung nodule localization needle
- 苏械注准 20242021492
- Valid until
- 14 July 2029
- Manufacturing licence
- Class III, Jiangsu Provincial MPA
- Licensed scope
- III 01-04; II 02-15
Standards applied
- Quality management
- GB/T 42061-2022 (ISO 13485:2016)
- Risk management
- GB/T 42062-2022 (ISO 14971:2019)
- Production
- Medical device GMP, sterile annexes
- Electrical safety
- GB 9706.1-2020
- Microwave therapy equipment
- GB 9706.206-2020
- Electromagnetic compatibility
- YY 9706.102-2021
- External marking
- YY 0899-2020, clause 4.2
Type-test reports
- Reports on file
- 10
- Generator
- 4 reports — electrical safety & EMC
- Needle
- 6 reports — mechanical, microwave, chemical
- Availability
- On request, under NDA
Electrical safety & EMC
Tested on LG-MWS-11A and LG-MWS-10A to GB 9706.1-2020, GB 9706.206-2020 and YY 9706.102-2021. Report numbers 2023-WT-1269-AF/EF and 2023-WT-1270-AF/EF, Beijing Zhongguancun Shuimu Medical Technology.
Mechanical, microwave, chemical
Tested on LG-MWA-03B and LG-MWB-02B — puncture force, rigidity, cooling flow, VSWR, insertion loss, shaft temperature and EO residue. Reports 2023-WT-2008/2009-AF/EF and STI-20230822-035SC.