HomeChinaAnhui MedPurest Medical Technology Co.

Anhui MedPurest Medical Technology Co.

China · Anqing · www.medpurest.cn
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000020935

This company has registrations in European Union, United States, Brazil, Saudi Arabia, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
7UDI-DI device records
Class I 7
USUnited StatesFDA openFDA
46listed device types
Class I 40Class II 6Class III 0
plus 47 registration records and 1 510(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
4registered 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
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
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 Union7 raw hits, 0 excluded, 7 confirmed
United States47 registration records, 1 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Saudi Arabia4 confirmed, 0 excluded
Manufacturer names merged into this page: ANHUI MEDPUREST MEDICAL TECHNOLOGY CO.,LTD · ANHUI MEDPUREST MEDICAL TECHNOLOGY CO., LTD · Anhui MedPurest Medical Technology CO.,Ltd。 · Anhui MedPurest Medical Technology Co., Ltd.

Regulatory identity

EU manufacturer SRN
CN-MF-000020935
EU authorised representative
Prolinx GmbH

Company information

Country
China
City
Anqing
Website
www.medpurest.cn
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineNuclear Medicine & Molecular ImagingDosimetry & radiation safety

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

12021 · K202532

FDA listed device types

showing 8 of 46
Cap, Surgical 1Gauze / Sponge,Nonresorbable For External Use 1Forceps 1Forceps, Tooth Extractor, Surgical 1First Aid Kit Without Drug 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Blade, Scalpel 1Bedding, Disposable, Medical 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06971751380601Sterile Surgical drapes with hole&adhesiveClass I
EU06971751380571Sterile Surgical drapesClass I
EU06971751380557Sterile Surgical drapesClass I
EU16971751380585sterile surgical drapes with holeClass I
USK202532Disposable Surgical Gowns2021-08-21
BR81655770069Macacão de proteção individual cirúrgicoClass I
SAME0000007947SFDAA00006Disposable Isolation gown
SAME0000007947SFDAA00005UTCARE

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