Identity
- Trade Name
- BIOSOFT EUDAMED
- Device Name
- BIOSOFT EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- BSF1610C-GLP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860028923 EUDAMED
- Basic UDI-DI
- B-08033860028923 EUDAMED8033860BIOEFT01U5 EUDAMED
- EMDN Code
- A0102010102 SHEARING BIOPSY GUNS 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
Biosoft by Biopsybell Srl — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860028923 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860028923 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 63db67a6-c4ac-4ecb-84e6-a776e118af04 61 fields · synced Jun 20, 2026
- EUDAMED 27aeba5e-eb29-4dcb-96e9-68b1f132c77f 61 fields · synced May 16, 2026