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Kka150118
EUDAMEDFDA UDIClass I (EU MDR)
Ref KKA150118Model EOS WIRELESS ARef KKA150418Model DELIGHT WIRELESSRef KKA140518Model EOS NEXT
Identity
- Trade Name
- EOS NEXT FDA UDIEOS WIRELESS A FDA UDIDELIGHT WIRELESS FDA UDI
- Generic Name
- Head-worn lamp FDA UDI
- Device Name
- Lighting system FDA UDI
- Model / Reference
- EOS WIRELESS A EUDAMEDFDA UDIKKA150118 EUDAMEDEOS NEXT EUDAMEDFDA UDIDELIGHT WIRELESS EUDAMEDFDA UDIKKA150418 EUDAMEDKKA140518 EUDAMED
- Description
- Lighting system FDA UDI
Identifiers
- Catalog Number
- KKA140518 FDA UDIKKA150118 FDA UDIKKA150418 FDA UDI
- Primary DI / UDI-DI
- 08057147024781 EUDAMEDFDA UDI08057147022893 EUDAMEDFDA UDI08057147024798 EUDAMEDFDA UDI
- Basic UDI-DI
- 8057147ILL005QL EUDAMED8057147ILL006QN EUDAMED8057147ILL004QJ EUDAMED
- FDA Product Code
- HPP FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Head-worn lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4335 FDA UDI
- Market of Registration
- Italy 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
Kka150118 by Univet Loupes Spa — 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 | 8057147ILL005QL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Univet Loupes Spa
- EUDAMED SRN
- IT-MF-000027104
Sources (6)
- EUDAMED 8aefc67d-3d6b-4d59-90bf-9d3967389928 61 fields · synced Jul 18, 2026
- FDA UDI 2f260545-8fc8-4fa5-9c66-8941030ac876 34 fields · synced May 30, 2026
- FDA UDI c5f0b7ac-e3c8-4524-bab3-08ed2d96b20b 34 fields · synced May 30, 2026
- FDA UDI ec5387b8-5662-4617-be35-7e9c1cf90b77 34 fields · synced May 30, 2026
- EUDAMED 8b364efb-f11c-42d4-9c45-6fde2843f5ae 61 fields · synced Jul 9, 2026
- EUDAMED 30f37c23-eb00-4968-8568-cb07549ebbfa 61 fields · synced Jul 18, 2026