Identity
- Trade Name
- IGNIS 160 F EUDAMED
- Device Name
- IGNIS 160 Lampy operacyjne EUDAMED
- Model / Reference
- IGNIS 160 F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904708713024 EUDAMED
- Basic UDI-DI
- 5904708713IGNIS160Z2 EUDAMED
- Direct Marketing DI
- 05904708713024 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Ignis 160 F by FAE Famed Łódź S.A. — 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 | 5904708713IGNIS160Z2 | Class I | Active |
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Manufacturer
- Manufacturer
- FAE Famed Łódź S.A.
- EUDAMED SRN
- PL-MF-000018775
Sources (1)
- EUDAMED 9defb4f8-0e03-4e1f-a6a8-849bccce2875 61 fields · synced Jun 20, 2026