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Axelgaard Manufacturing Co., Ltd.

✓ Record-verifiedregistrations found in 8 marketsEU SRN US-MF-000009382

This company has registrations in European Union, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Australia, 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

98UDI-DI device records

Class I 98

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class I 3

BRBrazilANVISA

7registered devices

Class I 1Class II 6

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

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

5 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union98 raw hits, 0 excluded, 98 confirmed

United States0 registration records, 0 510(k), 0 PMA, 2 excluded

United Kingdom3 confirmed, 0 excluded

Brazil7 confirmed, 0 excluded

Saudi Arabia7 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: AXELGAARD MANUFACTURING CO. LTD · AXELGAARD MANUFACTURING CO LTD · AXELGAARD MANUFACTURING CO. LTD. · Axelgaard Manufacturing Co., Ltd.

Regulatory identity

EU manufacturer SRN: US-MF-000009382
EU authorised representative: Axelgaard Manufacturing Co., Ltd.
UK responsible person: MedTec Consulting Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	03770018808345	actiTENS - Sublimed	Class I
EU	00851913006456	UltraStim Snap Blue	Class I
EU	00856817005482	PALS	Class I
EU	00851913006098	Little PALS	Class I
UK	17460	Little PALS	Class I
UK	65318	PALS	Class I
UK	35995	PALS Clinical	Class I
BR	81044969003	Eletrodo Autoadesivo TENS - Axelgaard	Class II
BR	81504799237	Eletrodos de Neuroestimulação	Class II
BR	80284450002	ELETRODOS NEUROESTIMULADOR	Class II
SA	ME0000007769SFDAA00003	ValuTrode	—
SA	ME0000007769SFDAA00004	ValuTrode Neurostimulation Electrodes	—
CA	9299	PALS NEUROSTIMULATION ELECTRODES	Class II

Axelgaard Manufacturing Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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