HomeGermanybiotrics bioimplants AG

biotrics bioimplants AG

Germany · Berlin · www.biotrics.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN DE-MF-000006864

This company has registrations in European Union, United States, South Korea, Australia — 4 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
3UDI-DI device records
Class I 1Class III 2
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
Class Is (sterile) 1
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 Union3 raw hits, 0 excluded, 3 confirmed
United States1 registration records, 0 510(k), 0 PMA
Manufacturer names merged into this page: BIOTRICS BIOIMPLANTS AG

Regulatory identity

EU manufacturer SRN
DE-MF-000006864

Company information

Country
Germany
City
Berlin
Website
www.biotrics.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOncology & Advanced TherapiesCell & gene therapy systems

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

Barrier, Animal Source, Intraoral 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04260639190114biocade® dura 1x1 cmClass III
EU04260639190039biocade® 2x3 cmClass III
EU04260639190022botiss grafterClass I

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