HomeTunisiaSO.F.A.P Société de Fabrication des Articles Pharmaceutiques

SO.F.A.P Société de Fabrication des Articles Pharmaceutiques

Tunisia · Tunis · www.sofapmedical.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN TN-MF-000023623

This company has registrations in European Union, United States — 2 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
49UDI-DI device records
Class I 17Class IIa 32
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(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
pendingnot queried
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 Union49 raw hits, 0 excluded, 49 confirmed
United States0 registration records, 1 510(k), 0 PMA
Brazil0 confirmed, 1 excluded

Regulatory identity

EU manufacturer SRN
TN-MF-000023623
EU authorised representative
Obelis s.a.

Company information

Country
Tunisia
City
Tunis
Website
www.sofapmedical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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 510(k) clearances by year

11986 · K861646

Registration details (sample)

MarketIdentifierNameClass / date
EU06192493101716Class I
EU06192493101624Class IIa
EU06192493100474Class IIa
EU06192493100733Class I
USK861646BIO-CARB D16000, D16001, AND D170001986-08-07

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