HomeJapanBEAR Medic Corporation

BEAR Medic Corporation

Japan · Tokyo · www.bearmedic-en.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN JP-MF-000018095

This company has registrations in European Union, United States, Brazil, Canada, Taiwan, Singapore, Israel — 7 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
16UDI-DI device records
Class IIa 16
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 3 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class II 1
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
1active device licences
Class III 1
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 Union48 raw hits, 32 excluded, 16 confirmed
United States3 registration records, 0 510(k), 0 PMA, 5 excluded
United Kingdom0 confirmed, 2 excluded
Brazil1 confirmed, 0 excluded
Canada1 confirmed, 2 excluded
Manufacturer names merged into this page: BEAR MEDIC CORPORATION · BEAR Medic Corporation

Regulatory identity

EU manufacturer SRN
JP-MF-000018095
EU authorised representative
Advena Limited

Company information

Country
Japan
City
Tokyo
Website
www.bearmedic-en.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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

Suture, Nonabsorbable, Synthetic, Polyamide 1Clamp, Vascular 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04544607401540Class IIa
EU04544607401533Class IIa
EU04544607401526Class IIa
EU04544607401519Class IIa
BR81528780001Micro Clip vascular descartável BEARClass II
CA81765USP 5-0 DOUBLE-ARMED STAINLESS STEEL WIRE SUTUREClass III

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