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Intraox
EUDAMEDClass IIa (EU MDR)
Ref IOF140305Ref IOF160305Ref IOF150305Ref IOF180305
Identity
- Trade Name
- INTRAOX EUDAMED
- Device Name
- INTRAOX EUDAMED
- Model / Reference
- IOF140305 EUDAMEDIOF160305 EUDAMEDIOF150305 EUDAMEDIOF180305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860008994 EUDAMED08033860008932 EUDAMED08033860029951 EUDAMED08033860009014 EUDAMED
- Basic UDI-DI
- B-08033860008994 EUDAMEDB-08033860008932 EUDAMEDB-08033860029951 EUDAMEDB-08033860009014 EUDAMED
- EMDN Code
- A03040102 INTRAOSSEOUS INFUSION KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Intraox by Biopsybell Srl — 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-08033860008994 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (4)
- EUDAMED 15f4869c-9bc6-4be2-babd-50eeaa23b216 61 fields · synced Aug 1, 2026
- EUDAMED 685563ca-7a5f-4449-94d7-3add177bdd61 61 fields · synced Jul 12, 2026
- EUDAMED f86e06a9-2e4d-4948-8326-1209981c6504 61 fields · synced Jul 15, 2026
- EUDAMED c047a88e-4f24-4c24-99ba-eb9620d5d670 61 fields · synced Aug 1, 2026