Identity
- Trade Name
- OPTYFILL EUDAMED
- Device Name
- SUBCHONDRAL BONE MARROW LESIONS (BML) SYSTEMS EUDAMEDOPTYFILL EUDAMED
- Model / Reference
- OPF1110C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860030834 EUDAMED
- Basic UDI-DI
- 8033860SUBFT01C6H EUDAMEDB-08033860030834 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optyfill by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860SUBFT01C6H | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860SUBFT01C6H | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 10591e8b-6e47-4e3f-964b-935aa987a3c5 61 fields · synced Aug 1, 2026
- EUDAMED 4fee286a-4041-4483-83eb-e19d6ec86151 61 fields · synced Aug 1, 2026