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Mt. Derm GmbH

Germany · Berlin

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel, Russia — 6 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 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

23registered devices

Class I 12Class II 11

24 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States5 registration records, 3 510(k), 0 PMA

Brazil23 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: MT.DERM GmbH · MT.DERM MEDICAL PRODUCTS PRIVATE LIMITED · MT. DERM GMBH · MT.DERM GMBH · MT DERM GMBH · MT.DERM GMBH (BLOHM)

Same-named companies — This database also contains companies with near-identical names: MT. DERM MEDICAL PRODUCTS PVT LTD, MT.DERM MEDICAL PRODUCTS PRIVATE LIMITED. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233709	Exceed Unlimited	2024-02-23
US	K182407	Exceed Microneedling device	2019-07-19
US	K180778	Exceed Microneedling Device	2018-09-07
BR	80344980059	MAQUINAS CHEYENNE	Class I
BR	80827000003	Cartuchos de agulhas Linelle	Class II
BR	80344989016	CARTUCHO COM AGULHAS CHEYENNE	Class II

Mt. Derm GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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