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Iliac Marrow
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IM1408Ref IM1610Ref IM1815Ref IM1607
Identity
- Trade Name
- ILIAC MARROW EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone marrow biopsy procedure kit FDA UDI
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDNEEDLE FOR BONE-MARROW BIOPSY FDA UDI
- Model / Reference
- IM1408 EUDAMEDIM1610 EUDAMEDIM1815 EUDAMEDIM1607 EUDAMEDILIAC MARROW FDA UDI
- Description
- NEEDLE FOR BONE-MARROW BIOPSY FDA UDI
Identifiers
- Catalog Number
- IM1607 FDA UDI
- Primary DI / UDI-DI
- 08033860022082 EUDAMED08033860011352 EUDAMED08033860010096 EUDAMED08033860002558 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMED
- 510(k) Number
- K130616 FDA UDI
- FDA Product Code
- KNW FDA UDIFCG FDA UDI
- EMDN Code
- A01020201 ILIAC-STERNAL BIOPSY NEEDLES AND KITS EUDAMED
- GMDN Term
- Bone marrow biopsy procedure kit 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 70 Millimeter FDA UDINeedle Gauge — 16 Gauge FDA UDI
Iliac Marrow by Biopsybell Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 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 (5)
- EUDAMED d62439db-5e3d-47ae-ad7e-f7673ae70563 61 fields · synced Aug 3, 2026
- EUDAMED 6ba98de5-6253-4900-9ad4-165aea1f80c6 61 fields · synced May 17, 2026
- EUDAMED be06124b-c661-4220-a273-93230beb2d4a 61 fields · synced May 17, 2026
- EUDAMED 4f72286e-1890-40f0-9008-2ce8ff3e1164 61 fields · synced May 19, 2026
- FDA UDI 68b01ba0-65a1-4488-aa98-6936bf61e177 37 fields · synced May 29, 2026