Identity
- Trade Name
- D.A.R.T. EUDAMED
- Device Name
- CEMENT INJECTION SYSTEMS FOR MINI-INVASIVE BONE SURGERY EUDAMEDD.A.R.T. EUDAMED
- Model / Reference
- BI-BF2403716 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860027728 EUDAMED
- Basic UDI-DI
- 8033860SFFT01CU2 EUDAMEDB-08033860027728 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
D.a.r.t. 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 | 8033860SFFT01CU2 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860SFFT01CU2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED ab1652a7-6488-4c1d-b61e-b7fc27922976 61 fields · synced Jul 29, 2026
- EUDAMED 8fdadd44-a9ed-4af6-ab85-6bf451a53ef0 61 fields · synced Jul 29, 2026