HomeChinaZhejiang Geyi Medical Instrument Co.,Ltd

Zhejiang Geyi Medical Instrument Co.,Ltd

China · 杭州 · www.zjgeyi.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000020887Unified social credit code 913301085966243588

This company holds 29 NMPA certificates in China and has registrations in European Union, United States, Brazil, South Korea, Israel — 5 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
29China registrations
Class II 25Class III 4
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class IIa 180Class IIb 120
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
9registered devices
Class II 9
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
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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 Union774 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States0 registration records, 1 510(k), 0 PMA
China29 certificates (Class III 4 / II 25 / I 0), as of 2026-09-04
Brazil9 confirmed, 0 excluded
Manufacturer names merged into this page: Zhejiang Geyi Medical Instrument Co, Ltd. · ZHEJIANG GEYI MEDICAL INSTRUMENT CO. LTD · ZHEJIANG GEYI MEDICAL INSTRUMENT CO, LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000020887
EU authorised representative
MedPath GmbH
Unified social credit code
913301085966243588
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
144
Annual revenue
RMB 10–30M
Website
www.zjgeyi.com
Product categories
手术室及急救

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
2012-06-05
Registered capital
CNY 22,000,000
Paid-in capital
CNY 14,400,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-07-28
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SMEGazelle enterprise

Business registration data from Tianyancha, as of 2026-09-03. 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

12025 · K252468

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243021248一次性使用结扎夹及带夹连发施夹器Class III
CN国械注准20243021243一次性结扎夹Class III
CN国械注准20243010582一次性使用腹腔内窥镜高频手术器械Class III
CN国械注准20243010462一次性使用双极电凝钳Class III
EU06925830183713Class IIa
EU06925830148125Class IIa
EU06925830167584Class IIa
EU06925830199356Class IIa
USK252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)2025-12-16
BR10289680145Cânula com trocarte descartável com lâmina para procedimentos endoscópClass II
BR10289680143Cânula com trocarte descartável para procedimentos endoscópicos GEYI MClass II
BR10289680154Conjunto de cânulas com trocarte descartável com lâmina e acessórios pClass II

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