HomeTürkiyeArden Medikal AŞ

Arden Medikal AŞ

Türkiye · Ankara · www.ardenmedikal.com.tr
✓ Record-verifiedregistrations found in 3 marketsEU SRN UK-MF-000053945

This company has registrations in European Union, United States, Australia — 3 overseas markets. EU UDI-DI records ≥292, the first 300 verified individually. 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
≥292UDI-DI device records
Class I 292
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 0Class III 0unclassified 1
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 Union806 raw hits, 8 excluded, 292 confirmed. Large result set — only the first 300 verified
United States2 registration records, 0 510(k), 0 PMA, 3 excluded
United Kingdom0 confirmed, 8 excluded
Manufacturer names merged into this page: ARDEN MEDICAL LTD.
Same-named companies — This database also contains companies with near-identical names: Arden Medical Systems, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

EU manufacturer SRN
UK-MF-000053945
EU authorised representative
EUCEREP B.V.

Company information

Country
Türkiye
City
Ankara
Website
www.ardenmedikal.com.tr
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationImplants & prosthetics

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

Dressing, Wound, Drug 1Splint, Extremity, Inflatable, External 1

Registration details (sample)

MarketIdentifierNameClass / date
EU05065006483146UriasClass I
EU05065006483139UriasClass I
EU05065006483122UriasClass I
EU05065006483108UriasClass I

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