Identity
- Trade Name
- ORTHOPLASTY EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- SUBCHONDRAL BONE MARROW LESIONS (BML) SYSTEMS EUDAMEDORTHOPLASTY EUDAMEDSUBCHONDRAL BONE PLASTY FDA UDI
- Model / Reference
- SUBFIL1315C-EM EUDAMEDSUB1110C EUDAMEDORTHOPLASTY FDA UDI
- Description
- SUBCHONDRAL BONE PLASTY FDA UDI
Identifiers
- Catalog Number
- SUB1110C FDA UDI
- Primary DI / UDI-DI
- 08033860037192 EUDAMED08033860030278 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860SUBFT01C6H EUDAMEDB-08033860037192 EUDAMEDB-08033860030278 EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 11 Gauge FDA UDILength — 100 Millimeter FDA UDI
Orthoplasty by Biopsybell Srl — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| 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 |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (5)
- EUDAMED 85b52cba-3b2a-4a9e-8149-a5bb0b5203bb 61 fields · synced Jul 26, 2026
- EUDAMED 706b3ec7-e70b-49ae-96bd-757418496d75 61 fields · synced May 18, 2026
- FDA UDI 51eaa71e-5a4b-4439-a48d-b8278ae05c2b 36 fields · synced May 30, 2026
- EUDAMED 422c5e9d-5034-4474-a2cf-384a9ad52d64 61 fields · synced Jun 18, 2026
- EUDAMED 6fd8fa26-4134-4c5b-b9c3-8c808ab68a6d 61 fields · synced Jul 23, 2026