Identity
- Trade Name
- BONE MARROW EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDBONE MARROW EUDAMED
- Model / Reference
- 180960 EUDAMED180965 EUDAMED180910 EUDAMED180935 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860039981 EUDAMED08033860040000 EUDAMED08033860039943 EUDAMED08033860039967 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860040000 EUDAMEDB-08033860039943 EUDAMEDB-08033860039967 EUDAMED
- EMDN Code
- A01020201 ILIAC-STERNAL BIOPSY 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
Bone Marrow by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860BIOEFT01U5 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860BIOEFT01U5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (7)
- EUDAMED d1ce533e-1be0-41b1-b35b-9964decb154a 61 fields · synced Jul 22, 2026
- EUDAMED 9463eed6-592a-44a9-a655-11c9dffe72b3 61 fields · synced May 18, 2026
- EUDAMED 59ddba2a-17bf-4442-8d14-a63916e49131 61 fields · synced May 18, 2026
- EUDAMED 6a7900e7-58f1-4ac2-927f-999805d313f0 61 fields · synced May 18, 2026
- EUDAMED 05a03590-3e08-4b09-b99d-ea102959c21d 61 fields · synced Jul 9, 2026
- EUDAMED d71b9f0b-ab3c-45f1-b764-b76cd19537eb 61 fields · synced Jul 21, 2026
- EUDAMED 3d9fd060-e315-400c-bf60-9cb99cb1f9c7 61 fields · synced Jul 22, 2026