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VorOtek X-Series HeadLight
EUDAMEDFDA UDIClass I (EU MDR)
Ref VLHH-DAModel VorOtek Scopes and Lights Range
Identity
- Trade Name
- VorOtek X-Series HeadLight EUDAMEDFDA UDI
- Generic Name
- Head-worn lamp FDA UDI
- Device Name
- VorOtek Scopes and Lights Range EUDAMEDVorOtek X-Series HeadLight - HeadBand. Fully Portable Surgical Quality Dimmable LED Illumination with Adjustable Spot Size. Includes Power Pack, Charger & Carry Case. FDA UDI
- Model / Reference
- VorOtek Scopes and Lights Range EUDAMEDVLHH-DA EUDAMEDFDA UDI
- Description
- VorOtek X-Series HeadLight - HeadBand. Fully Portable Surgical Quality Dimmable LED Illumination with Adjustable Spot Size. Includes Power Pack, Charger & Carry Case. FDA UDI
Identifiers
- Catalog Number
- VLHH-DA FDA UDI
- Primary DI / UDI-DI
- 09348227001181 EUDAMEDFDA UDI
- Basic UDI-DI
- 93482270VHWBPSLRK9 EUDAMED
- Direct Marketing DI
- 09348227001181 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
- Netherlands 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
No
FDA UDI
VorOtek X-Series HeadLight by Vorotek Pty Ltd — 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 | 93482270VHWBPSLRK9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Vorotek Pty Ltd
- EUDAMED SRN
- AU-MF-000002859
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 01be1f84-67b4-4cb0-8827-a09e5f1c9676 61 fields · synced Jul 19, 2026
- FDA UDI 5fba92db-adef-43dd-92a6-bc761eb36cb6 34 fields · synced May 30, 2026