HomeChinaMicroTech Medical ( Hangzhou ) Co., Ltd.

MicroTech Medical ( Hangzhou ) Co., Ltd.

China · 杭州 · www.microtechmd.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000001157Unified social credit code 9133011056875135XF

This company holds 26 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, South Korea, Australia, Hong Kong, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥27, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
26China registrations
Class I 1Class II 16Class III 9
as of 2026-09-04 · NMPA records sit under a different credit code (73163324) — possibly an affiliated entity
EUEuropean UnionEUDAMED
≥27UDI-DI device records
Class IIb 27
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
9registered device records
Class IIa 2Class IIb 4Class C – Self-testing or Near-patient Testing 1IVD Annex II List B 2
BRBrazilANVISA
1registered devices
Class I 1
6 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Business type not stated 1
AUAustraliaTGA ARTG
2active ARTG entries
IIb 2
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
5active registrations
Class 2b 5
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union315 raw hits, 273 excluded, 27 confirmed. Large result set — only the first 300 verified
United States1 registration records, 1 510(k), 0 PMA, 5 excluded
China26 certificates (Class III 9 / II 16 / I 1), as of 2026-09-04
United Kingdom9 confirmed, 3 excluded
Brazil1 confirmed, 0 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: MICROTECH MEDICAL (HANGZHOU) CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000001157
EU authorised representative
CMC Medical Devices & Drugs SL
UK responsible person
NPZ technology Ltd
Unified social credit code
9133011056875135XF
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Employees
1000–5000
Annual revenue
over RMB 500M
Company type
Manufacturer
Website
www.microtechmd.com
Product categories
康复 & 养老医用诊察和监护器械注输、护理和防护器械

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12020 · K193340

FDA listed device types

System, Test, Blood Glucose, Over The Counter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263141648胰岛素泵Class III
CN国械注准20263141406胰岛素泵用皮下输液器Class III
CN国械注准20263071832持续葡萄糖监测系统Class III
CN国械注准20253142625胰岛素泵用储药器组件Class III
EU06958590315834LinX10Class IIb
EU06958590303985WELLIONClass IIb
EU06958590307617WELLIONClass IIb
EU06958590306177WELLIONClass IIb
UK63262Insulin Infusion SetsClass IIa
UK35838Insulin Infusion Pump ReservoirsClass IIb
UK51083Ambulatory Insulin Infusion PumpsClass IIb
USK193340GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System2020-09-11
BR80560310103PANCARESClass I

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