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VorOtek M Scope - HeadBand Model.
EUDAMEDFDA UDIClass I (EU MDR)
Ref VSMHModel VorOtek Scopes and Lights Range
Identity
- Trade Name
- VorOtek M Scope - HeadBand Model. EUDAMEDVorOtek M Scope FDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDI
- Device Name
- VorOtek Scopes and Lights Range EUDAMEDVorOtek M Scope - HeadBand. Plate Magnification with Fully Integrated Surgical Quality Dimmable LED Illumination. Includes 2, 4 & 6 Dioptre Plate Magnifiers, Power Pack, Charger & Carry Case. FDA UDI
- Model / Reference
- VorOtek Scopes and Lights Range EUDAMEDVSMH EUDAMEDFDA UDI
- Description
- VorOtek M Scope - HeadBand. Plate Magnification with Fully Integrated Surgical Quality Dimmable LED Illumination. Includes 2, 4 & 6 Dioptre Plate Magnifiers, Power Pack, Charger & Carry Case. FDA UDI
Identifiers
- Catalog Number
- VSMH FDA UDI
- Primary DI / UDI-DI
- 09348227000153 EUDAMEDFDA UDI
- Basic UDI-DI
- 93482270VHWBPSLRK9 EUDAMED
- FDA Product Code
- HJH FDA UDI
- EMDN Code
- Z12019080 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES 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 M Scope - HeadBand Model. 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 bc41ab9f-7028-4c30-a029-c4f9174cbe6c 61 fields · synced Jul 22, 2026
- FDA UDI 03a3028f-808b-4370-8452-406032badc6f 34 fields · synced May 30, 2026