Identity
- Trade Name
- UNLUX SYSTEM EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone marrow biopsy procedure kit FDA UDI
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDUNLUX SYSTEM EUDAMEDNEEDLE FOR BONE-MARROW BIOPSY FDA UDI
- Model / Reference
- ULSEC1115C EUDAMEDUNLUX SYSTEM FDA UDI
- Description
- NEEDLE FOR BONE-MARROW BIOPSY FDA UDI
Identifiers
- Catalog Number
- ULSEC1115C FDA UDI
- Primary DI / UDI-DI
- 08033860002008 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860002008 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
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 150 Millimeter FDA UDINeedle Gauge — 11 Gauge FDA UDI
Unlux System by Biopsybell Srl — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| 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 |
| 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 be5873eb-8640-4824-8fed-38a5d97e099b 61 fields · synced Jul 12, 2026
- EUDAMED bfd92515-c736-45ee-abf3-2a189555ec6b 61 fields · synced May 19, 2026
- FDA UDI 08bba3d2-48fa-46e9-bee0-135b89c3e849 37 fields · synced May 29, 2026