Identity
- Trade Name
- HELIOS 160 C EUDAMEDHELIOS 160/160 C EUDAMED
- Device Name
- HELIOS 160 Lampy operacyjne EUDAMED
- Model / Reference
- HELIOS 160 C EUDAMEDHELIOS 160/160 C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904708713093 EUDAMED05904708713116 EUDAMED
- Basic UDI-DI
- 5904708713HELIOS160KC EUDAMED
- Direct Marketing DI
- 05904708713093 EUDAMED05904708713116 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
Helios 160 C 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 | 5904708713HELIOS160KC | Class I | Active |
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Manufacturer
- Manufacturer
- FAE Famed Łódź S.A.
- EUDAMED SRN
- PL-MF-000018775
Sources (2)
- EUDAMED f560e0cc-8a70-4566-8c43-f01875ec1c5d 61 fields · synced Jul 31, 2026
- EUDAMED cd90de20-547e-4994-81c7-aeff8c53445b 61 fields · synced May 19, 2026