Identity
- Trade Name
- BIOPSY HANDY EUDAMED
- Device Name
- BIOPSY HANDY EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- 900138 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860043827 EUDAMED
- Basic UDI-DI
- B-08033860043827 EUDAMED8033860BIOEFT01U5 EUDAMED
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES 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
Biopsy Handy 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-08033860043827 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860043827 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED f704b339-0883-4a0d-bf11-d0db016be0c5 61 fields · synced Jul 12, 2026
- EUDAMED 2c84b9a1-53d5-49b9-8a70-fde26efa7225 61 fields · synced May 17, 2026
- EUDAMED 0a602bf9-fa0a-4a2d-a8aa-475f8725d75b 61 fields · synced Jun 14, 2026