Identity
- Trade Name
- BIOSOFT EUDAMED
- Device Name
- BIOSOFT EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- BSF1410C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860005351 EUDAMED
- Basic UDI-DI
- B-08033860005351 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-08033860005351 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860005351 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED c21c95c1-a8a7-4b98-be28-6b500c1fa72a 61 fields · synced Jul 24, 2026
- EUDAMED c5653164-2faf-43ea-9391-8b8bf92e9649 61 fields · synced May 19, 2026