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Sternobell
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RN1865Ref RN1875Ref RN1340Ref RN1675Ref RN1465
Identity
- Trade Name
- STERNOBELL EUDAMEDBIOPSYBELL SRL 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
- RN1865 EUDAMEDRN1875 EUDAMEDRN1340 EUDAMEDRN1675 EUDAMEDRN1465 EUDAMEDSTERNOBELL FDA UDI
- Description
- Needle for bone-marrow biopsy FDA UDI
Identifiers
- Catalog Number
- RN1340 FDA UDI
- Primary DI / UDI-DI
- 08033860004514 EUDAMED08033860004538 EUDAMED08033860042875 EUDAMEDFDA UDI08033860004491 EUDAMED08033860013073 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMED
- 510(k) Number
- K130616 FDA UDI
- FDA Product Code
- FCG FDA UDIKNW 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 13 Gauge FDA UDILength — 40 Millimeter FDA UDI
Sternobell 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 (6)
- EUDAMED 4bbb2f5c-99b5-4f99-ba91-0dda9bc016db 61 fields · synced Aug 4, 2026
- EUDAMED 9c839424-966b-43f5-b8a3-dcb6d11206c8 61 fields · synced May 17, 2026
- EUDAMED da23a91c-7b9b-4fb9-860e-226f6315cd8e 61 fields · synced May 17, 2026
- EUDAMED f136f36f-f1fa-4fbf-b9db-beb88a4b5916 61 fields · synced May 18, 2026
- EUDAMED 4426adc4-3547-4a60-8e5d-cb37aed88ffe 61 fields · synced May 18, 2026
- FDA UDI a78af7c9-3e10-4d73-92e7-d6bf262919bd 37 fields · synced May 30, 2026