Identity
- Trade Name
- PENTA63NSO EUDAMED
- Device Name
- LAMPADE SCIALITICHE PER USO CHIRURGICO E PER LA DIAGNOSI EUDAMED
- Model / Reference
- PENTA63N EUDAMED
Identifiers
- Primary DI / UDI-DI
- B880PENTA63N0 EUDAMED
- Basic UDI-DI
- ++B880LUMINAIREPM EUDAMED
- Direct Marketing DI
- B880PENTA63N0 EUDAMED
- EMDN Code
- Z12010701 FIXED 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
Category: Operating room light system
Penta63nso by RIMSA P. LONGONI S.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 b49cc5a7-42da-4833-a639-38f31855a4f9 61 fields · synced Jun 18, 2026