Identity
- Trade Name
- UNLUX SYSTEM EUDAMED
- Device Name
- UNLUX SYSTEM EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- ULS1118.5C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860020866 EUDAMED
- Basic UDI-DI
- B-08033860020866 EUDAMED8033860BIOEFT01U5 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, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860020866 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860020866 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 963edca7-6124-4004-b1e2-3db46f3e668b 61 fields · synced Jun 19, 2026
- EUDAMED 50ca57c7-b07b-4041-8b2d-f5c97cc4c859 61 fields · synced May 19, 2026