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0bie1610/075
EUDAMEDClass IIa (EU MDR)
Ref 0BIE1610/075Model Disposable needle for bone biopsy
Identity
- Trade Name
- 0BIE1610/075 EUDAMED
- Device Name
- Disposable needle for iliac-sternal aspiration explant version EUDAMED
- Model / Reference
- Disposable needle for bone biopsy EUDAMED0BIE1610/075 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053670913219 EUDAMED
- Basic UDI-DI
- B-08053670913219 EUDAMED
- EMDN Code
- A01020201,A01020202 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
Category: Bone marrow biopsy needle, single-use
0bie1610/075 by Biomedical S.r.l. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone marrow biopsy needle, single-use.
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class II
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class I
- MEDBONE — Medax Unipersonale Srl · Class II
- Bone Marrow Biopsy — Argon Medical Devices, Inc. · Class I
- Monoject — Cardinalhealth · Class II
- MEDLOCK — Medax Unipersonale Srl · Class II
- Bone Marrow Biopsy Needle, RBN-116 — RANFAC CORP. · Class II
- Faset — Dio Medical Co., Ltd. · U
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-08053670913219 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biomedical S.r.l.
- EUDAMED SRN
- IT-MF-000027821
Sources (1)
- EUDAMED c20c2c9c-ec0d-47ac-83bf-295a43e3d374 61 fields · synced Jun 18, 2026