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0bm1415
EUDAMEDClass IIa (EU MDR)
Ref 0BM1415Model Disposable needle for soft tissues biopsy
Identity
- Trade Name
- 0BM1415 EUDAMED
- Device Name
- Disposable guillotine needle for manual biopsy on soft tissues EUDAMED
- Model / Reference
- Disposable needle for soft tissues biopsy EUDAMED0BM1415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053670913745 EUDAMED
- Basic UDI-DI
- B-08053670913745 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
0bm1415 by Biomedical S.r.l. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08053670913745 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biomedical S.r.l.
- EUDAMED SRN
- IT-MF-000027821
Sources (1)
- EUDAMED 9113589d-1f3c-42b4-8e15-b8e4ef543bbd 61 fields · synced Jun 18, 2026