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RAUMEDIC AG

Germany · Helmbrechts · www.raumedic.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN DE-MF-000006155

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, South Korea, Australia, Israel — 9 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

39UDI-DI device records

Class I 38Class IIa 1

USUnited StatesFDA openFDA

2listed device types

Class I 1Class II 0Class III 1

plus 2 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

12registered device records

Class I 4Class IIa 2Class IIb 1Class III 3Custom-made 1Custom-made - Class I 1

BRBrazilANVISA

3registered devices

Class II 3

11 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

4device registrations

CLASS B 1CLASS D 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

14active ARTG entries

Class I 3Class III 7IIa 2IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 Union39 raw hits, 0 excluded, 39 confirmed

United States2 registration records, 6 510(k), 0 PMA, 3 excluded

United Kingdom12 confirmed, 0 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: RAUMEDIC, Incorporated. · RAUMEDIC AG

Regulatory identity

EU manufacturer SRN: DE-MF-000006155
UK responsible person: RAUMEDIC UK LIMITED

Business registration

LEI: 529900LAHT8Y32ZXW195
Registration status: Active
Legal form: Aktiengesellschaft (AG)
Incorporated: 2003-10-22
Registration authority: Commercial Register, no. HRB 3643
Registry record updated: 2026-05-13

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

22011 · K112017

12012 · K120252

12013 · K130529

12017 · K171666

12025 · K250285

FDA listed device types

Dispenser, Liquid Medication 1Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04057834024227	OMNIBAR E5F	Class IIa
EU	04057834097665	LDD Kit 1	Class I
EU	04057834024791	NPS2 SpaceLabs	Class I
EU	04057834027341	ICP-TEMP-Adapter Philips/HP	Class I
UK	42773	Adapter Non-Luer	Custom-made - Class I
UK	42773	Adapter Non-Luer	Custom-made
UK	36545	Wide range power adapter RAUMED Home ICP
US	K250285	NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL	2025-08-29
US	K171666	MPR2 logO DATALOGGER	2017-07-06
US	K130529	RAUMEDIC-PTO-MONITORING-SYSTEM	2013-10-25
BR	80208360007	KIT DE ACESSÓRIOS PARA DRENAGEM RAUMEDIC	Class II
BR	80208360033	ACESSÓRIOS PARA IMPLANTAÇÃO DE CATETERES DE PRESSÃO RAUMEDIC	Class II
BR	80208360056	Acessórios RAUMEDIC	Class II