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Unlux System
EUDAMEDClass IIa (EU MDR)
Ref ULS1517CRef ULS0918.5CRef ULS1118CRef ULS1520CRef ULS1515CRef ULS0918CRef ULS1307
Identity
- Trade Name
- UNLUX SYSTEM EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- ULS1517C EUDAMEDULS0918.5C EUDAMEDULS1118C EUDAMEDULS1520C EUDAMEDULS1515C EUDAMEDULS0918C EUDAMEDULS1307 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860015664 EUDAMED08033860020842 EUDAMED08033860019228 EUDAMED08033860016821 EUDAMED08033860016784 EUDAMED08033860018566 EUDAMED08033860002145 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 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
Unlux System by Biopsybell Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 78198125-aa68-445c-aa2e-901da420ad4d 61 fields · synced Jul 23, 2026
- EUDAMED 55b024f4-29d1-4cdd-80db-f997557c3fa3 61 fields · synced May 17, 2026
- EUDAMED 8659d83e-943d-4faa-a462-4dcee2281bd4 61 fields · synced May 18, 2026
- EUDAMED 3e29cb80-5b42-4ea0-b160-f7c94ab15f1d 61 fields · synced May 18, 2026
- EUDAMED b48633d5-13fa-4b2f-97bb-5cfa29f1fecf 61 fields · synced May 18, 2026
- EUDAMED fffc8d2d-60a5-4280-9a43-f992c1414cae 61 fields · synced May 18, 2026
- EUDAMED 28762ac0-ca55-4075-9d97-36dc0258363d 61 fields · synced May 18, 2026