Identity
- Trade Name
- VISIANO 10-1 P S10 EUDAMEDVISIANO 10-1 FDA UDI
- Generic Name
- Fixed examination/treatment room light FDA UDI
- Device Name
- Examination light EUDAMEDLED Examination Light, 2105364, Pin Mount FDA UDI
- Model / Reference
- D15783000 EUDAMEDP S10 FDA UDI
- Description
- LED Examination Light, 2105364, Pin Mount FDA UDI
Identifiers
- Catalog Number
- D15783000 FDA UDI
- Primary DI / UDI-DI
- 07640158710272 EUDAMEDFDA UDI
- Basic UDI-DI
- 76401587118S EUDAMED
- FDA Product Code
- KZF FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Fixed examination/treatment room light FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6320 FDA UDI
- Market of Registration
- Germany 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
Visiano 10-1 P S10 by Derungs Licht AG — 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 | 76401587118S | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Derungs Licht AG
- EUDAMED SRN
- CH-MF-000015827
- Authorised Representative
- Derungs Medical GmbH DE-AR-000033841
Sources (2)
- EUDAMED c12beab4-6d8d-4791-aba9-0244f40ad7cf 61 fields · synced Jul 24, 2026
- FDA UDI 249478d9-1394-4134-a402-1c600fb84df2 34 fields · synced May 30, 2026