Identity
- Trade Name
- OSTEOBELL EXPLANT EUDAMEDOSTEOBELL EXPLANT WITH FILTER EUDAMED
- Device Name
- OSTEOBELL EXPLANT EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- OBE1111TC-FLT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860043605 EUDAMED
- Basic UDI-DI
- B-08033860043605 EUDAMED8033860BIOEFT01U5 EUDAMED
- EMDN Code
- A01020202 BONE MARROW EXPLANT NEEDLES AND KITS 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
Category: Bone marrow biopsy needle, single-use
Osteobell Explant by Biopsybell Srl — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone marrow biopsy needle, single-use.
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- 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/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860043605 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860043605 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 59163633-3d71-4117-934e-f60e4e71d645 61 fields · synced Jul 9, 2026
- EUDAMED 6b457ce3-8888-4b0d-98f5-c4ba7d5c329a 61 fields · synced May 17, 2026