Identity
- Trade Name
- PRIMA-FIX EUDAMED
- Device Name
- LAMPADE SCIALITICHE PER USO CHIRURGICO E PER LA DIAGNOSI EUDAMED
- Model / Reference
- PRIMA-FIX EUDAMED
Identifiers
- Primary DI / UDI-DI
- B880PRIMAFIX0 EUDAMED
- Basic UDI-DI
- ++B880LUMINAIREPM EUDAMED
- Direct Marketing DI
- B880PRIMAFIX0 EUDAMED
- EMDN Code
- Z12010702 MOBILE SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Prima-Fix by RIMSA P. LONGONI S.r.l. — Class I — 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 | ++B880LUMINAIREPM | Class I | Active |
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Manufacturer
- Manufacturer
- RIMSA P. LONGONI S.r.l.
- EUDAMED SRN
- IT-MF-000009224
Sources (1)
- EUDAMED bdb5b2d5-0897-4e9d-9ff8-37b5f06ae0bf 61 fields · synced Jun 19, 2026