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Visiano 10-1 P S10
EUDAMEDFDA UDIClass I (EU MDR)
Ref D15732000Ref D16063000Ref D15756000Ref D15959000
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, 2111193, Pin Mount FDA UDI
- Model / Reference
- D15732000 EUDAMEDD16063000 EUDAMEDD15756000 EUDAMEDD15959000 EUDAMEDP S10 FDA UDI
- Description
- LED Examination Light, 2111193, Pin Mount FDA UDI
Identifiers
- Catalog Number
- D15959000 FDA UDI
- Primary DI / UDI-DI
- 07630795100970 EUDAMED07640158711705 EUDAMED07630795100550 EUDAMED07640158710319 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 (5)
- EUDAMED eacf8708-9951-46a3-9a8a-f0ef67f38ca9 61 fields · synced Aug 1, 2026
- EUDAMED a99f1f5f-84cb-4f11-9bc6-ea09de793751 61 fields · synced May 17, 2026
- EUDAMED 5b891212-980b-4c0c-8489-a9be47c486d0 61 fields · synced May 17, 2026
- EUDAMED 1b92bf51-8199-47a9-9642-dc7c9dba61fa 61 fields · synced May 18, 2026
- FDA UDI 193397c8-338d-4b0c-9047-105f858118c2 34 fields · synced May 30, 2026