HomeChinaZHEJIANG AOKI MEDICAL,DRESSING CO.,LTD

ZHEJIANG AOKI MEDICAL,DRESSING CO.,LTD

China · 温州 · www.aoqimed.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000040819Unified social credit code 91330327683147676Y

This company holds 9 NMPA certificates in China and has registrations in European Union, United States, Brazil, Saudi Arabia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
9China registrations
Class II 9
as of 2026-09-04
EUEuropean UnionEUDAMED
12UDI-DI device records
Class IIa 12
USUnited StatesFDA openFDA
16listed device types
Class I 16Class II 0Class III 0
plus 16 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 Union12 raw hits, 0 excluded, 12 confirmed
United States16 registration records, 0 510(k), 0 PMA
China9 certificates (Class III 0 / II 9 / I 0), as of 2026-09-04
Brazil1 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: ZHEJIANG AOKI MEDICAL DRESSING CO., LTD · Zhejiang Aoki Medical Dressing Co., Ltd · Zhejiang Aoki Medical Dressing Co. LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000040819
EU authorised representative
Caretechion GmbH
Unified social credit code
91330327683147676Y
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
56
Annual revenue
RMB 100–500M
Website
www.aoqimed.com
Product categories
医用耗材

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
2009-01-07
Registered capital
CNY 66,000,000
Paid-in capital
CNY 50,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-08-27
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SME

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 listed device types

showing 8 of 16
Pad, Eye 1Gauze / Sponge,Nonresorbable For External Use 1Scissors, Medical, Disposable 1Accessory, Surgical Apparel 1Bag, Ice 1Gauze/Sponge, Internal, X-Ray Detectable 1Dress, Surgical 1Splint, Hand, And Components 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20242141429水凝胶敷料Class II
CN浙械注准20242141428硅凝胶疤痕修复贴Class II
CN浙械注准20232140088聚氨酯泡沫敷料Class II
CN浙械注准20232140086藻酸盐敷料Class II
EU36927876943291AOKIClass IIa
EU26927876943294AOKIClass IIa
EU16927876943297AOKIClass IIa
EU36927876943284AOKIClass IIa
BR80299880168Máscara Facial DescartávelClass I
SAME0000012330SFDAA00010PARAID
SAME0000012330SFDAA00011PARAID

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