HomeChinaZhejiang Fert Medical Device Co.,Ltd.

Zhejiang Fert Medical Device Co.,Ltd.

China · 嘉兴 · www.zjfert.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000012602Unified social credit code 913304007570594186

This company holds 35 NMPA certificates in China and has registrations in European Union, Brazil, South Korea, Australia, Israel, Russia — 6 overseas markets. EU UDI-DI records ≥28, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
35China registrations
Class II 12Class III 23
as of 2026-09-04
EUEuropean UnionEUDAMED
≥28UDI-DI device records
Class I 4Class IIb 24
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
10registered devices
Class I 1Class 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
1GMP quality-system certificates
Manufacturing 1
AUAustraliaTGA ARTG
2active ARTG entries
IIa 1IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 2b 1
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 Union449 raw hits, 272 excluded, 28 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 1 excluded
China35 certificates (Class III 23 / II 12 / I 0), as of 2026-09-04
United Kingdom0 confirmed, 11 excluded
Brazil10 confirmed, 0 excluded
Manufacturer names merged into this page: ZHEJIANG FERT MEDICAL DEVICE CO., LTD. · ZHEJIANG FERT MEDICAL DEVICE CO. LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000012602
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
913304007570594186
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
392
Annual revenue
RMB 100–500M
Website
www.zjfert.com
Product categories
注输、护理和防护器械医用耗材手术室及急救呼吸、麻醉和急救器械

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.

Business registration

Registration status
Active
Incorporated
2003-12-03
Registered capital
CNY 88,888,888
Paid-in capital
CNY 88,888,888
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2021-04-07
Recognitions
National High-Tech EnterpriseTechnology-based SMEAbove-designated-size industrial enterprise
Listing
Listed on the NEEQ

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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243030826一次性使用输液接头消毒帽Class III
CN国械注准20223140821一次性使用带防针刺针微孔过滤输液器Class III
CN国械注准20223140026一次性使用延长管Class III
CN国械注准20213141026一次性使用微量泵连接管Class III
EU26952803712407Disposable infusion pumpClass IIb
EU16952803712400Disposable infusion pumpClass IIb
EU06952803712403Disposable infusion pumpClass IIb
EU26952803712391Disposable infusion pumpClass IIb
BR10289680207Bomba de infusão intravenosa soft Fert MedicalClass II
BR10289689056Bomba De Infusão Intravenosa Fert MedicalClass II
BR10289689057Bomba De Infusão Intravenosa UV Fert MedicalClass II

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