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Lohmann & Rauscher GmbH

Austria · Wien · www.lohmann-rauscher.com

✓ Record-verifiedregistrations found in 12 marketsEU SRN UK-MF-000036885

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

Class I 157Class IIa 95Class IIb 33Class III 15

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

12listed device types

Class I 11Class II 1Class III 0

plus 36 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

42registered device records

Class I 24Class IIa 4Class IIb 9Class III 4System or Procedure Pack 1

BRBrazilANVISA

26registered devices

Class I 23Class II 3

33 including historic records

SASaudi ArabiaSFDA

74registered imported devices

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

CACanadaMDALL

0active device licences

5 including historic records

TWTaiwanTFDA

14valid device licences

Class I 14

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

50active ARTG entries

Class I 30IIa 1IIb 6Class Is (sterile) 13

HKHong KongMDACS

3valid listings

Class III 2Class IV 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 5

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 Union369 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States36 registration records, 0 510(k), 0 PMA

United Kingdom42 confirmed, 0 excluded

Brazil26 confirmed, 0 excluded

Saudi Arabia74 confirmed, 0 excluded

Manufacturer names merged into this page: LOHMANN & RAUSCHER GMBH & CO. KG · Lohmann & Rauscher GmbH · Lohmann & Rauscher s.r.o · Lohmann & Rauscher s.r.o. · LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO. KG · LOHMANN & RAUSCHER INTERNACIONAL GMBH & CO.KG

Regulatory identity

EU manufacturer SRN: UK-MF-000036885
EU authorised representative: Lohmann & Rauscher International GmbH & Co. KG
UK responsible person: L&R Medical UK Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05037696100993	ActiFast Purple	Class I
EU	05037696100986	ActiFast Purple	Class I
EU	05037696100979	ActiFast Purple	Class I
EU	05037696400611	ActiFast Beige	Class I
UK	34864	Curapor 10 x 20cm	Class I
UK	33056	Cellona Plaster of Paris	Class I
UK	10668	Cellona shoe dressing protection	Class I
BR	10349310029	Cellacare® Epi Classic - Cotoveleira ortopédica	Class I
BR	80102511589	MOLLELAST® HAFT LATEXFREE - BANDAGEM COESIVA	Class I
BR	80102511590	MOLLELAST® HAFT BANDAGEM COESIVA	Class I
SA	ME0000001996SFDAA00168	Rosidal® TC	—
SA	ME0000001996SFDAA00164	Cellacast Soft Semi-rigid Casting Tape	—

Lohmann & Rauscher GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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