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danumed Medizintechnik GmbH

Germany · Regensburg · www.danumed.com

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United Kingdom, Brazil, Australia, Israel — 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

0UDI-DI device records

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

6registered device records

Class I 2System or Procedure Pack 4

BRBrazilANVISA

6registered devices

Class I 3Class II 3

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

10active ARTG entries

Class I 1IIb 3Class Is (sterile) 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 Kingdom6 confirmed, 0 excluded

Brazil6 confirmed, 0 excluded

Manufacturer names merged into this page: DANUMED MEDIZINTECHNIK GMBH

Regulatory identity

UK responsible person: Psephos Limited

Registration details (sample)

Market	Identifier	Name	Class / date
UK	62495	danumed Extension Set - Non-Sterile	System or Procedure Pack
UK	62256	danumed extension set for gastrostomy button	System or Procedure Pack
UK	38565	danuButton Compact Set	System or Procedure Pack
BR	10212990370	Dispositivo Medidor de Estoma Danumed®	Class I
BR	10212990371	EXTENSÃO COM CONECTOR PARA SONDA DANUMED®	Class I
BR	10212999023	Sonda Gastrotube Danumed®	Class II

danumed Medizintechnik GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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