MEDICEL AG

Switzerland · Altenrhein Sankt Gallen

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 3Class II 0Class III 0

plus 12 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 2Class II 11

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

TWTaiwanTFDA

14valid device licences

Class I 13Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

23active ARTG entries

Class I 1IIa 22

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

6active registrations

Class 1 2Class 2a 4

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.

United States12 registration records, 6 510(k), 0 PMA, 1 excluded

Brazil13 confirmed, 0 excluded

Manufacturer names merged into this page: MEDICEL AG

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252540	ACCUJECT Injector Set 2.1-1P (LP604590)	2025-09-16
US	K231106	Accuject Refra Injector AR2900	2023-09-19
US	K101134	VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430	2010-08-09
BR	80420209011	Injetores Viscoject-BIO	Class II
BR	80420209012	Injetores Accuject	Class II
BR	10161029009	Accuject Dual	Class II

MEDICEL AG

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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