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BETATEX SPA

Italy · Assisi (PG) · betatex.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN IT-MF-000009955

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
13UDI-DI device records
Class I 3Class IIa 4Class IIb 3Class III 3
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 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
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 Union13 raw hits, 0 excluded, 13 confirmed
United States1 registration records, 0 510(k), 0 PMA
United Kingdom0 confirmed, 1 excluded
Manufacturer names merged into this page: BETATEX S.P.A.

Regulatory identity

EU manufacturer SRN
IT-MF-000009955

Company information

Country
Italy
City
Assisi (PG)
Website
betatex.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 listed device types

Drape, Surgical, Ent 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08053807813108Class III
EU08053807811494TECNODRAPEClass III
EU08056215771466SET NEURORADIOLOGIAClass IIa
EU08053300789344LACCI VASCOLARIClass III

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