HomeDONGGUAN XIN YI HEALTHCARE PRODUCTS FACTORY.

DONGGUAN XIN YI HEALTHCARE PRODUCTS FACTORY.

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
4listed device types
Class I 4Class II 0Class III 0
plus 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
36registered devices
Class I 36
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
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.

United States4 registration records, 0 510(k), 0 PMA, 10 excluded
Brazil36 confirmed, 4 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: Bazhou City Xin an Town Hexin Medical Material Factory · NANHAI YI XIN PLASTIC TABLEWARE MANUFACTURING CO LTD · DONGGUAN XIN YI HEALTHCARE PRODUCTS FACTORY.

Company information

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 listed device types

Container, Liquid Medication, Graduated 1Point, Paper, Endodontic 1Utensil, Eating 1Specula Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80102511231PACOTE CIRÚRGICO PARA EXTREMIDADES INFERIORESClass I
BR80102511232PACOTE CIRÚRGICO PARA ORTOPEDIA IClass I
BR80102511227PACOTE CIRÚRGICO PARA ORTOPEDIA0 V (Quadril)Class I

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