Osteobell Explant
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- OSTEOBELL EXPLANT EUDAMEDBIOPSYBELL SRL FDA UDI
- Generic Name
- Bone marrow explant needle FDA UDI
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDOSTEOBELL EXPLANT EUDAMED
- Model / Reference
- OBE1111T-O EUDAMEDOBE1111T-PR EUDAMEDOSTEOBELL EXPLANT FDA UDI
Identifiers
- Catalog Number
- OBE1111T-O FDA UDI
- Primary DI / UDI-DI
- 08033860027308 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860027308 EUDAMED
- 510(k) Number
- K130616 FDA UDI
- FDA Product Code
- KNW FDA UDIFCG FDA UDI
- EMDN Code
- A01020202 BONE MARROW EXPLANT NEEDLES AND KITS EUDAMED
- GMDN Term
- Bone marrow explant needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 110 Millimeter FDA UDINeedle Gauge — 11 Gauge FDA UDI
Category: Bone marrow biopsy needle, single-use
Osteobell Explant by Biopsybell Srl — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone marrow biopsy needle, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8033860BIOEFT01U5 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 8033860BIOEFT01U5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED f176a5f7-23d8-4956-b66b-ad5732104f24 61 fields · synced Jul 11, 2026
- EUDAMED 518e815d-3cb6-4c3c-995d-580c67575876 61 fields · synced May 17, 2026
- FDA UDI f1680286-e13e-4869-83ea-058f7e8aa1bf 36 fields · synced May 29, 2026