0bile1632/095

EUDAMED

Class IIa (EU MDR)

Ref 0BILE1632/095Model Disposable needle for bone biopsy

by Biomedical S.r.l.

Identity

Trade Name: 0BILE1632/095 EUDAMED
Device Name: Disposable needle for iliac-sternal aspiration with anatomic grip - explant version EUDAMED
Model / Reference: Disposable needle for bone biopsy EUDAMED
0BILE1632/095 EUDAMED

Identifiers

Primary DI / UDI-DI: 08053670913387 EUDAMED
Basic UDI-DI: B-08053670913387 EUDAMED
EMDN Code: A01020201,A01020202 EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Italy EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Bone marrow biopsy needle, single-use

0bile1632/095 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-08053670913387	Class IIa	Active

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Manufacturer

Manufacturer: Biomedical S.r.l.
EUDAMED SRN: IT-MF-000027821

Sources (1)

EUDAMED e962f4a1-cc82-4ad8-998b-59b11cb450dd 61 fields · synced Sep 17, 2026