Identity
- Trade Name
- Bloxoto EUDAMED
- Model / Reference
- Soluzione Otologica EUDAMED81OTO005PT-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ITMF2494581OTO005PT01DX EUDAMED
- Basic UDI-DI
- B-ITMF2494581OTO005PT01DX EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bloxoto by Drugs Minerals and Generics Italia S.r.l. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-ITMF2494581OTO005PT01DX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Drugs Minerals and Generics Italia S.r.l.
- EUDAMED SRN
- IT-MF-000024945
Sources (1)
- EUDAMED 3234fd29-637a-447a-9223-fd65eb05a64e 61 fields · synced Oct 6, 2026