Identity
- Trade Name
- OZONEEDLE EUDAMED
- Device Name
- OZONEEDLE EUDAMED
- Model / Reference
- OZ2217ECSF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860015190 EUDAMED
- Basic UDI-DI
- B-08033860015190 EUDAMED
- EMDN Code
- A010199 NEEDLES FOR INFUSION AND COLLECTION - OTHER 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
Ozoneedle 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-08033860015190 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (1)
- EUDAMED 6ee28488-75be-422a-a6f8-a8e878d34ca5 61 fields · synced Jun 18, 2026