Identity
- Trade Name
- BIOPSY HANDY EUDAMED
- Device Name
- BIOPSY HANDY EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMEDSOFT TISSUES BIOPSY NEEDLES (SEMIAUTOMATIC AND AUTOMATIC) EUDAMED
- Model / Reference
- 900128 EUDAMED900118 EUDAMED900146 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860043742 EUDAMED08033860043551 EUDAMED08033860043889 EUDAMED
- Basic UDI-DI
- B-08033860043742 EUDAMED8033860BIOEFT01U5 EUDAMEDB-08033860043889 EUDAMEDB-08033860043551 EUDAMED8033860BIOAFT01SR 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-08033860043742 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860043742 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (10)
- EUDAMED 945dace5-7934-4815-bad7-283518ddec85 61 fields · synced Aug 4, 2026
- EUDAMED 51d6eb1d-e164-4094-a4b4-9728ef156396 61 fields · synced May 18, 2026
- EUDAMED 516c4ba1-907e-44a0-b81b-1693ba14f56e 61 fields · synced May 18, 2026
- EUDAMED f4b9d49a-826f-44bb-9537-3fdf312e27a0 61 fields · synced May 19, 2026
- EUDAMED 960f9666-004f-4a05-9fe4-f4ce145e3457 61 fields · synced May 19, 2026
- EUDAMED ffbb89e1-922d-44c2-ba19-869ca5c6fc44 61 fields · synced May 19, 2026
- EUDAMED d85d5d95-1931-4ebe-a7cd-7868b97de960 61 fields · synced Jun 19, 2026
- EUDAMED 0be1095e-458b-490d-a756-cc7155a4b222 61 fields · synced Jun 19, 2026
- EUDAMED e5d7fb46-5a0e-4254-8152-8dcffea48913 61 fields · synced Jul 9, 2026
- EUDAMED 2841f87d-421e-429f-a909-e27e5ccdc775 61 fields · synced Aug 4, 2026