Identity
- Trade Name
- ORTHO-PACK EUDAMED
- Device Name
- SUBCHONDRAL BONE MARROW LESIONS (BML) SYSTEMS EUDAMEDORTHO-PACK EUDAMED
- Model / Reference
- ORP1110C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860041007 EUDAMED
- Basic UDI-DI
- 8033860SUBFT01C6H EUDAMEDB-08033860041007 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
Ortho-Pack 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 5a973ace-d5a2-48d7-80ef-aa44d368f21e 61 fields · synced Jul 21, 2026
- EUDAMED 439ecac6-47f3-493f-a376-ce8ebe0b6f89 61 fields · synced Jul 15, 2026