HomeYILINK (TIANJIN) BIOTECHNOLOGY TECHNOLOGY CO., LTD

YILINK (TIANJIN) BIOTECHNOLOGY TECHNOLOGY CO., LTD

✓ 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
1listed device types
Class I 0Class II 1Class III 0
plus 3 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class II 6
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 States3 registration records, 3 510(k), 0 PMA
Brazil6 confirmed, 0 excluded
Manufacturer names merged into this page: Yilink (Tianjin) Biotechnology Co., Ltd. · YILINK (TIANJIN) BIOTECHNOLOGY TECHNOLOGY CO., LTD
Same-named companies — This database also contains companies with near-identical names: Yilink (Tianjin) Biotechnology Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

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 510(k) clearances by year

12022 · K222520
12023 · K222513
12024 · K242400

FDA listed device types

Powder, Porcelain 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242400Dental porcelain powder2024-10-10
USK222513Glass Ceramics2023-02-10
USK222520Zirconia Block2022-11-14
BR80360119015Bloco de dissilicato de lítio- YILINKClass II
BR83417289001Bloco de Zircônia BMSClass II
BR83417289002Bloco de Dissilicato de Lítio BMSClass II

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