Identity
- Trade Name
- Premio 40 Light EUDAMEDPremio 40 - Light FDA UDI
- Generic Name
- Fixed examination/treatment room light FDA UDI
- Device Name
- Premio 40 Light EUDAMEDThe PREMIO 40 Light is an active device intended to illuminate an area or a point of the patient's body in the visible spectrum by a light emission which can be filtered and / or frequency. FDA UDI
- Model / Reference
- 112953 EUDAMEDPREMIO 40 FDA UDI
- Description
- The PREMIO 40 Light is an active device intended to illuminate an area or a point of the patient's body in the visible spectrum by a light emission which can be filtered and / or frequency. FDA UDI
Identifiers
- Catalog Number
- 112953 FDA UDI
- Primary DI / UDI-DI
- 03760262493381 EUDAMEDFDA UDI
- Basic UDI-DI
- 3760262491301YA EUDAMED
- FDA Product Code
- KYT FDA UDI
- EMDN Code
- Z129005 GENERIC PHOTOSTIMULATORS EUDAMED
- GMDN Term
- Fixed examination/treatment room light FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6350 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Premio 40 Light by Sedatelec — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3760262491301YA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sedatelec
- EUDAMED SRN
- FR-MF-000020946
Sources (2)
- EUDAMED 88a84411-f948-4f94-9584-eb1b7e86980e 61 fields · synced Jul 10, 2026
- FDA UDI 7ccd57e2-ef74-4bb7-8557-eda7b6c19d2e 34 fields · synced May 30, 2026