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VorOtek O Scope HeadBand 3D
EUDAMEDFDA UDIClass I (EU MDR)
Ref VSOH-3DModel VorOtek Scopes and Lights Range
Identity
- Trade Name
- VorOtek O Scope HeadBand 3D EUDAMEDVorOtek O Scope FDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDI
- Device Name
- VorOtek Scopes and Lights Range EUDAMEDVorOtek O Scope - HeadBand - 3D. 12mm Converged Binocular Optics & Fully Integrated LED Illumination with 3 dioptre Magnification. Adjustable IPD. Includes Power Pack, Charger & Carry Case. FDA UDI
- Model / Reference
- VorOtek Scopes and Lights Range EUDAMEDVSOH-3D EUDAMEDFDA UDI
- Description
- VorOtek O Scope - HeadBand - 3D. 12mm Converged Binocular Optics & Fully Integrated LED Illumination with 3 dioptre Magnification. Adjustable IPD. Includes Power Pack, Charger & Carry Case. FDA UDI
Identifiers
- Catalog Number
- VSOH-3D FDA UDI
- Primary DI / UDI-DI
- 09348227001938 EUDAMEDFDA UDI
- Basic UDI-DI
- 93482270VHWBPSLRK9 EUDAMED
- FDA Product Code
- HJH FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical binoculars, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.5120 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 O Scope HeadBand 3D 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 56e7688a-2e78-477e-b526-6556ce14191c 61 fields · synced Jul 22, 2026
- FDA UDI 65d82267-ad87-4bf9-8f7f-250e98d7ee8d 34 fields · synced May 30, 2026