Home›USA›AccuVein Inc.

AccuVein Inc.

✓ Record-verifiedregistrations found in 8 marketsEU SRN US-MF-000013817

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Australia, Hong Kong, Israel — 8 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

1UDI-DI device records

Class IIa 1

USUnited StatesFDA openFDA

1listed device types

Class I 1Class II 0Class III 0

plus 2 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class I 2Class IIa 1

BRBrazilANVISA

3registered devices

Class I 3

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

1active device licences

Class II 1

4 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class I 7IIa 1

HKHong KongMDACS

1valid listings

Class II 1

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 Union1 raw hits, 0 excluded, 1 confirmed

United States2 registration records, 0 510(k), 0 PMA

United Kingdom3 confirmed, 0 excluded

Brazil3 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: AccuVein Inc. · ACCUVEIN INC. · AccuVein, LLC · AccuVein Inc · ACCUVEIN, INC.

Regulatory identity

EU manufacturer SRN: US-MF-000013817
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00850019808018	AV500	Class IIa
UK	48040	AccuVein AV400	Class IIa
UK	65697	HF570	Class I
UK	42513	HF510	Class I
BR	10033439062	ACCUVEIN AV300	Class I
BR	10033430685	ACCUVEIN	Class I
BR	10290310080	AV500	Class I
CA	100646	ACCUVEIN AV400	Class II

AccuVein Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

Similar companies