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RoweMed AG - Medical 4 Life

Germany · Parchim · www.rowemed.de

✓ Record-verifiedregistrations found in 7 marketsEU SRN DE-MF-000005350

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia, Australia, Israel, 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

130UDI-DI device records

Class I 60Class IIa 70

USUnited StatesFDA openFDA

4listed device types

Class I 4Class II 0Class III 0

plus 4 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class I 3Class IIa 2

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered 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

2active ARTG entries

Class Is (sterile) 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 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 Union130 raw hits, 0 excluded, 130 confirmed

United States4 registration records, 0 510(k), 0 PMA

United Kingdom5 confirmed, 0 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: RoweMed AG - Medical 4 Life · RoweMed AG, Medical 4 Life

Regulatory identity

EU manufacturer SRN: DE-MF-000005350
UK responsible person: Psephos Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04250347604539	RoweEpiflow Neuraxial; 0,2 µm PET-Membran	Class IIa
EU	04250347605505	RoweEpiflow (PC) Neuraxial; 0,2 µm PET-Membran	Class IIa
EU	04250347604546	RoweEpiflow Neuraxial; 0,2 µm positiv geladene Nylon-Membran	Class IIa
EU	04250347604553	RoweEpiflow Neuraxial; 0,2 µm PES-Membran	Class IIa
UK	35072	RowePhil 25/0.2	Class IIa
UK	60822	RoweSpike II	Class I
UK	16628	RoweSpike II	Class I
SA	ME0000003460SFDAA00002	CentoSwab	—

RoweMed AG - Medical 4 Life

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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