HomeChinaCofoe Medical Technology Co., Ltd.

Cofoe Medical Technology Co., Ltd.

China · Changsha Hunan · www.cofoe.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000001077Unified social credit code 91430111696240992G

This company holds 200 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Singapore, Hong Kong, Israel — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
200China registrations
Class I 104Class II 95Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
149UDI-DI device records
Class I 54Class IIa 50IVD C 28ivd-annex-ii-list-b 14ivd-devices-self-testing 3
USUnited StatesFDA openFDA
22listed device types
Class I 15Class II 7Class III 0
plus 22 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
40registered device records
Class I 14Class IIa 10Class B – Self-testing or Near-patient Testing 1Class C – Self-testing or Near-patient Testing 11IVD Annex II List B 1IVD Devices for Self-Testing 3
BRBrazilANVISA
12registered devices
Class I 2Class II 10
this export covers Class I / II only (the cadastro route)
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
4device registrations
CLASS B 3CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
3valid listings
Class II 3
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
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 Union149 raw hits, 0 excluded, 149 confirmed
United States22 registration records, 1 510(k), 0 PMA
China200 certificates (Class III 1 / II 95 / I 104), as of 2026-09-04
United Kingdom40 confirmed, 0 excluded
Brazil12 confirmed, 0 excluded
Manufacturer names merged into this page: COFOE MEDICAL TECHNOLOGY CO.,LTD · COFOE MEDICAL TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000001077
EU authorised representative
RIOMAVIX SOCIEDAD LIMITADA
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91430111696240992G
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Changsha Hunan
Social-insurance enrolees
1,167
Website
www.cofoe.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsHome & self-testing

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.

Business registration

Registration status
Active
Incorporated
2009-11-19
Registered capital
CNY 235,897,000
Paid-in capital
CNY 235,897,000
Legal form
Joint-stock limited company (listed)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-06-23
Recognitions
National High-Tech EnterpriseManufacturing Single ChampionNational SRDI "Little Giant"Recognised enterprise technology centreState Key LaboratoryAdvanced technology service enterpriseAbove-designated-size industrial enterprise
Listing
Listed on the A-share market

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12024 · K230277

FDA listed device types

showing 8 of 22
Hearing Aid, Air-Conduction, Over The Counter 1Orthosis, Lumbar 1Garment, Protective, For Incontinence 1Adaptor, Hygiene 1Regulator, Pressure, Gas Cylinder 1Splint, Hand, And Components 1Solvent, Adhesive Tape 1Protector, Ostomy 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263400632幽门螺杆菌抗原检测试剂盒(胶体金法)Class III
CN湘械注准20262400123葡萄糖质控液Class II
CN湘械注准20262400121血糖试纸(葡萄糖脱氢酶法)Class II
CN湘械注准20262220122血糖测试仪Class II
EU06950715574393Ostomy Bag and AccessorieClass I
EU06950715573785CofoeClass I
EU06950715573945Alcohol WipeClass I
EU06950715573938Alcohol WipeClass I
UK66295Mesh NebulizerClass IIa
UK17988Alcohol WipeClass I
UK45617Automatic Upper Arm Blood Pressure MonitorClass IIa
USK230277Pulse Oximeter(Model OHT60,OXH78)2024-01-04
BR80795959009Oxímetro de Pulso DellamedClass II
BR82817610001Bolsa de ColostomiaClass I
BR80795959010Monitor Automático de Pressão Arterial para Pulso SUPERClass II

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