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Freudenberg Medical Europe GmbH

Germany · Kaiserslautern

✓ Record-verifiedregistrations found in 6 marketsEU SRN US-MF-000023823

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada — 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

86UDI-DI device records

Class I 59Class IIa 10Class IIb 17

USUnited StatesFDA openFDA

30listed device types

Class I 13Class II 15Class III 1unclassified 1

plus 55 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

28registered device records

Class I 22Class IIa 5Class IIb 1

BRBrazilANVISA

26registered devices

Class I 15Class II 11

31 including historic records

SASaudi ArabiaSFDA

17registered imported devices

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

CACanadaMDALL

8active device licences

Class II 8

15 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 Union86 raw hits, 0 excluded, 86 confirmed

United States55 registration records, 3 510(k), 0 PMA, 7 excluded

United Kingdom28 confirmed, 0 excluded

Brazil26 confirmed, 0 excluded

Saudi Arabia17 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: Freudenberg Medical, LLC · FREUDENBERG MEDICAL, LLC · Freudenberg Medical, SRL · FREUDENBERG MEDICAL EUROPE GMBH · Freudenberg Medical Inc, · Freudenberg Medical LLC

Regulatory identity

EU manufacturer SRN: US-MF-000023823
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

Business registration

LEI: 529900OF9JRYQMPUBQ69
Registration status: Active
Legal form: Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated: 1974-11-07
Registered address: Liebigstr. 2-8, Kaiserslautern, 67661
Registration authority: Commercial Register, no. HRB 31563
Registry record updated: 2026-01-15

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

22019 · K192422

12024 · K240763

FDA listed device types

showing 8 of 30

Instrument, Ent Manual Surgical 1Gauge, Measuring 1Tube, Laryngectomy 1Kit, Surgical Instrument, Disposable 1System, Skin Closure 1Tape And Bandage, Adhesive 1Catheter, Nasopharyngeal 1Applicator, Absorbent Tipped, Non-Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00848253003306	Blom-Singer® StomaSoft Laryngectomy Tubes, Non-Fenestrated, Non-sterile, 12/55mm	Class IIb
EU	00848253003290	Blom-Singer® StomaSoft Laryngectomy Tubes, Non-Fenestrated, Non-sterile, 12/36mm	Class IIb
EU	00848253003283	Blom-Singer® StomaSoft Laryngectomy Tubes, Non-Fenestrated, Non-sterile, 10/55mm	Class IIb
EU	00848253003276	Blom-Singer® StomaSoft Laryngectomy Tubes, Non-Fenestrated, Non-sterile, 10/36mm	Class IIb
UK	34864	Adhesive Bandage	Class I
UK	62095	Cleaning Brush, Long, 12mm-20mm 3ea	Class I
UK	46634	Blom-Singer Manometer Kit	Class I
US	K240763	FirstFit Surgical Kit	2024-12-18
US	K192422	Steerable Introducer 12F	2019-10-04
US	K191190	Steerable Introducer	2019-08-01
BR	81591120021	Tampa com filtro de espuma HumidiFilter® ATSV II Blom Singer®	Class II
BR	81591129002	Válvula ajustável para traqueostoma ATSV II Blom Singer®	Class II
BR	81591120018	Protetores de espuma para estoma Blom Singer®	Class I
SA	ME0000009158SFDAA00001	Shower Guard	—
SA	ME0000009158SFDAA00002	TruSeal	—
CA	6899	BLOM SINGER INSUFFLATION TEST SET	Class II
CA	8813	BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS	Class II
CA	9093	BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET-STERILE	Class II

Freudenberg Medical Europe GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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