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sfm medical devices GmbH

Germany · Wächtersbach

✓ Record-verifiedregistrations found in 7 marketsEU SRN DE-MF-000008166

This company has registrations in European Union, United States, United Kingdom, Canada, South Korea, Australia, Russia — 7 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

27UDI-DI device records

Class I 25Class IIa 2

USUnited StatesFDA openFDA

12listed device types

Class I 6Class II 6Class III 0

plus 15 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class I 4Class IIa 1

BRBrazilANVISA

0registered devices

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

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

European Union37 raw hits, 10 excluded, 27 confirmed

United States15 registration records, 3 510(k), 0 PMA

United Kingdom5 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SFM Medical Devices GmbH · SFM MEDICAL DEVICES GMBH

Regulatory identity

EU manufacturer SRN: DE-MF-000008166
UK responsible person: Qserve Group UK, Ltd.

FDA 510(k) clearances by year

12019 · K183187

22024 · K241976

FDA listed device types

showing 8 of 12

Electrode, Needle 1Probe, Radiofrequency Lesion 1Anesthesia Conduction Kit 1Set, I.V. Fluid Transfer 1System/Device, Pharmacy Compounding 1Generator, Lesion, Radiofrequency 1Device, Percutaneous, Biopsy 1Cannula, Surgical, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04063574832510	Transfer Set	Class I
EU	04063574846890	Transfer / Filter Set	Class I
EU	04063574773608	Transfer/ Filter Set	Class I
EU	04063574741997	Transfer/ Filterset	Class I
UK	16266	Filter 20µm	Class I
UK	16266	nextaro va , 13mm, 5µm Filter	Class I
UK	16627	Transfer Needle (Pencil-Point; 1,0 mm x 49 mm; needle length (pencil-point) 24,5 mm/ needle length (single bevel) 9 mm)	Class I
US	K241976	nextaro® va, 15mm, 5µm	2024-09-06
US	K240748	nextaro® v, 20/20	2024-04-16
US	K183187	nextaro Transfer System, nextaro va	2019-03-15

sfm medical devices GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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