Jinghang GuoyeMedical

Medical device contract manufacturing (CMO)

Manufactured under your registration.

Jinghang Guoye Medical is a dedicated device CMO in Nanjing. Microwave and radiofrequency ablation platforms — active generators and sterile single-use consumables — produced under a Class III manufacturing licence in an ISO Class 7 cleanroom.

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Class III manufacturing licence QMS to GB/T 42061-2022 (ISO 13485:2016) 600 m² ISO Class 7 cleanroom 17 patents & software copyrights
Single-use microwave ablation needles — registered configurations arranged diagonally

Why partners place production here

A dedicated CMO, not a factory with a catalogue.

Licensed manufacturing

Class III manufacturing licence from the Jiangsu Provincial Medical Products Administration; licensed scope III 01-04 and II 02-15. Production runs under medical device GMP.

Engineering-led transfer

In-house process and quality engineers handle design transfer, process validation and in-process control for both active and sterile devices.

Focused platform

One specialisation — microwave and radiofrequency ablation — so custom requirements are answered by the people who run the lines.

2,000m² total building area
600m² cleanroom, ISO Class 7
40,000localization needles per year
6registrations in force

The portfolio

Six registrations in production.

Each product below is manufactured on these lines under contract for its marketing authorisation holder. The same platform is open to production under your own registration.

Microwave ablation generator, trolley-mounted console
Active device2,450 MHz

Microwave ablation generator

Registration 国械注准20253010197. 2,450 MHz platform, 200 units a year, 72-hour burn-in per unit.

Single-use microwave ablation needle with output cable
Sterile18 configurations

Microwave ablation needle

Registration 国械注准20253010071. 18 registered configurations; shaft lengths 130/170/200 mm; dimensional tolerance within 0.05 mm.

Single-use lung nodule localization needle with four-claw anchor
SterileVATS

Lung nodule localization needle

Registration 苏械注准20242021492. Anchor and coil types; 40,000 units a year; pilot runs from 500 units.

Portable microwave ablation generator
PortableCompact

Portable MW generator

The same energy platform in a compact footprint for clinics and day procedures.

Single-use microwave ablation catheter
CatheterSingle-use

MW ablation catheter

Two series for lesions beyond a straight needle track.

Disposable puncture needle with coaxial cannula
AccessCoaxial

Puncture & access needles

Registration 浙械注准20252142036. Coaxial access for biopsy, drainage and instrument introduction.

Microwave ablation generator registration certificate国械注准 20253010197 Microwave ablation generator registration certificate, English translationGenerator · EN Single-use microwave ablation needle registration certificate国械注准 20253010071 Single-use microwave ablation needle registration certificate, English translationNeedle · EN Lung nodule localization needle registration certificate苏械注准 20242021492 Disposable radiofrequency ablation electrode registration certificate赣械注准 20242010142 Disposable radiofrequency ablation electrode registration certificate, English translationRF electrode · EN Venous stripping catheter registration certificate赣械注准 20242020151 Single-use puncture needle registration certificate浙械注准 20252142036 Type-test report cover pagesType-test reports Microwave ablation generator registration certificate国械注准 20253010197 Microwave ablation generator registration certificate, English translationGenerator · EN Single-use microwave ablation needle registration certificate国械注准 20253010071 Single-use microwave ablation needle registration certificate, English translationNeedle · EN Lung nodule localization needle registration certificate苏械注准 20242021492 Disposable radiofrequency ablation electrode registration certificate赣械注准 20242010142 Disposable radiofrequency ablation electrode registration certificate, English translationRF electrode · EN Venous stripping catheter registration certificate赣械注准 20242020151 Single-use puncture needle registration certificate浙械注准 20252142036 Type-test report cover pagesType-test reports

Patents & software copyrights

17 patents and software copyrights behind the platform.

Portable microwave ablation embedded system softwareSoftware copyright · portable embedded system Vertical microwave ablation display & control softwareSoftware copyright · display & control software Vertical microwave ablation embedded system softwareSoftware copyright · vertical embedded system Vertical microwave intelligent ablation sensing & communication systemSoftware copyright · sensing & communication Water-cooled curved-handle microwave ablation needleDesign patent · curved-handle needle Water-cooled straight-handle microwave ablation needleDesign patent · straight-handle needle Needle-angle assist device for CT-guided microwave ablationUtility model · CT needle-angle assist Repositionable breast localization deviceUtility model · breast localization device Lung nodule localization device with puncture guide needleUtility model · lung nodule localization Scaffold-style protective sheath for microwave ablation needlesUtility model · ablation needle sheath Balloon occlusion catheterUtility model · balloon occlusion catheter Lung nodule puncture localization deviceUtility model · lung puncture localization Patient posture monitoring device for lung surgeryUtility model · posture monitoring Anti-pneumothorax puncture assist deviceUtility model · anti-pneumothorax device Guide structure for venous strippersUtility model · venous stripper guide Water-cooled adjustable ablation electrodeUtility model · adjustable electrode Introducer tip for venous strippersUtility model · venous stripper tip Portable microwave ablation embedded system softwareSoftware copyright · portable embedded system Vertical microwave ablation display & control softwareSoftware copyright · display & control software Vertical microwave ablation embedded system softwareSoftware copyright · vertical embedded system Vertical microwave intelligent ablation sensing & communication systemSoftware copyright · sensing & communication Water-cooled curved-handle microwave ablation needleDesign patent · curved-handle needle Water-cooled straight-handle microwave ablation needleDesign patent · straight-handle needle Needle-angle assist device for CT-guided microwave ablationUtility model · CT needle-angle assist Repositionable breast localization deviceUtility model · breast localization device Lung nodule localization device with puncture guide needleUtility model · lung nodule localization Scaffold-style protective sheath for microwave ablation needlesUtility model · ablation needle sheath Balloon occlusion catheterUtility model · balloon occlusion catheter Lung nodule puncture localization deviceUtility model · lung puncture localization Patient posture monitoring device for lung surgeryUtility model · posture monitoring Anti-pneumothorax puncture assist deviceUtility model · anti-pneumothorax device Guide structure for venous strippersUtility model · venous stripper guide Water-cooled adjustable ablation electrodeUtility model · adjustable electrode Introducer tip for venous strippersUtility model · venous stripper tip
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Manufacturing services

Delivery you can schedule against.

Capacity, suppliers and inspection are arranged so your launch date does not wait on ours.

Personnel & training

Certified key positions

Key-position staff hold certifications with documented induction, annual training and assessment. Duties and authorisations are defined in writing.

Scheduling

15 to 21 days standard lead time

Multiple product families run in parallel on one site. Standard orders are scheduled and delivered within 15 to 21 days.

Supply chain

Vendor-managed inventory

Long-term supplier agreements support on-demand material supply and lower inventory held at either side.

InspectionTeam of four

Inspection at every stage

A dedicated four-person inspection team covers incoming, in-process and final release — raw materials, semi-finished and finished goods.

Quality management

Compliance is the baseline. The system is the proof.

Documented, auditable, and open to customer review before the first commercial batch.

Quality management system

GB/T 42061-2022, identical to ISO 13485:2016; production managed under medical device GMP including the sterile-device annexes.

Risk management

GB/T 42062-2022 (ISO 14971:2019) applied from design transfer through process validation and serial production.

Quality objectives

Customer satisfaction ≥ 95%; finished-product delivery conformity 100%.

Inside the plant

Photographed on site. Open for audit.

Laboratory, cleanroom, production line, offices and warehouse — our own facility, no stock imagery. Site visits and customer audits are welcome.

R&D & testing laboratory

Performance, electrical safety and biological evaluation testing in-house.

Engineers reviewing test records at the physical testing bench Microbiology laboratory with laminar-flow exhaust hoods Testing laboratory benches with instruments and calibration records Instrument bench with analytical equipment and fume hood

Cleanroom

ISO Class 7 (Class 10,000) suite with airlocks and gowning for sterile assembly and packaging.

Cleanroom entrance through fire-exit glass door Operator at the cleanroom window with material racks Gowning area with sink and garment rack Cleanroom corridor with glossy epoxy floor Stainless-steel worktables inside the cleanroom Cleanroom storage room with shelving and pass-through box

Production line

Generator assembly, commissioning and 72-hour burn-in on the production floor.

Microwave ablation generator on the production floor Assembly benches with fume extraction Row of generators during burn-in testing by the window Wide view of the production area with assembly stations

Offices

Engineering, regulatory affairs and commercial teams on one floor.

Engineer working on 3D device drawings Open-plan office of the regulatory and sales team Design engineer reviewing CAD models Tooling and fixture workbench in the engineering area

Warehouse

Controlled storage under FIFO for materials and finished goods.

Warehouse racks with labeled bins and turnover boxes Finished goods stacked on pallets Sterile product boxes in labeled storage lanes Packaging materials in the controlled storage area

Working together

From inquiry to serial supply.

01

Inquiry

Your device, target market, volumes, and the registration holder.

02

Feasibility

Drawings, materials and packaging reviewed under mutual NDA; written response within 24 hours.

03

Pilot & validation

Pilot batch from 500 units with process validation and full inspection records.

04

Serial supply

Agreed controls, retained batch records, delivery windows you can plan against.

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