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Black Forest Medical GmbH

Germany · Freiburg Im Breisgau

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel, Russia — 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

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 5Class II 1Class III 0

plus 21 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 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

2active device licences

Class II 2

4 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

Class I 7Class III 2IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 States21 registration records, 0 510(k), 0 PMA, 4 excluded

Brazil1 confirmed, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Black Forest Medical GmbH · BLACK FOREST MEDICAL NORTH AMERICA, INC. · BLACK FOREST MEDICAL GMBH

Same-named companies — This database also contains companies with near-identical names: BLACK FOREST MEDICAL NORTH AMERICA, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA listed device types

Holder, Head, Neurosurgical (Skull Clamp) 1Table, Surgical With Orthopedic Accessories, Ac-Powered 1Table, Operating-Room, Mechanical 1Headrest, Neurosurgical 1Tray, Surgical, Instrument 1Instrument, Surgical, Non-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10210550065	POSICIONADOR FIXADOR CIRURGICO DE CABECA DORO E ACESSORIOS	Class I
CA	74614	DORO BIPOLAR REUSABLE CABLES	Class II
CA	74615	DORO NON-STICK BIPOLAR FORCEPS	Class II

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Black Forest Medical GmbH

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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