Identity
- Trade Name
- OPTYCAST EUDAMED
- Device Name
- SYSTEMS FOR METAPHYSEAL FRACTURES EUDAMEDOPTYCAST EUDAMED
- Model / Reference
- OPC1112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860030865 EUDAMED
- Basic UDI-DI
- 8033860OSTEOFT01CDE EUDAMEDB-08033860030865 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
Optycast 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 | 8033860OSTEOFT01CDE | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860OSTEOFT01CDE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED a678457c-2921-4def-b955-cadfe39589b4 61 fields · synced Jun 19, 2026
- EUDAMED f2c7d8d9-a8dd-4986-ade6-8b42e4ccbaf7 61 fields · synced Jun 19, 2026