Identity
- Trade Name
- EOS WIRELESS FDA UDI
- Generic Name
- Head-worn lamp FDA UDI
- Device Name
- Lighting system FDA UDI
- Model / Reference
- EOS WIRELESS FDA UDI
- Description
- Lighting system FDA UDI
Identifiers
- Catalog Number
- KKA138118 FDA UDI
- Primary DI / UDI-DI
- 08057147000983 FDA UDI
- FDA Product Code
- HPP FDA UDI
- GMDN Term
- Head-worn lamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4335 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Head-worn lamp
Eos Wireless by Univet Loupes Spa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Head-worn lamp.
- M-ORTTL Assembly — QUALITY ASPIRATORS, INC. · Class I
- Quasar — ENOVA ILLUMINATION, INC · Class I
- Quantum — ENOVA ILLUMINATION, INC · Class I
- RADHUM4 — QUALITY ASPIRATORS, INC. · Class I
- Amimon — Amimon Inc. · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- MedLED Chrome — RIVERPOINT MEDICAL LLC · Class I
- Quasar — ENOVA ILLUMINATION, INC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Univet Loupes Spa
Sources (2)
- FDA UDI 9158107f-8ec7-43d7-bbdb-8011abbafcd0 34 fields · synced Jun 8, 2026
- EUDAMED 1 fields · synced Jun 2, 2026