Identity
- Trade Name
- LiNA OperåScope™ with HDMI cable & LCD FDA UDI
- Generic Name
- Rigid video hysteroscope FDA UDI
- Device Name
- LiNA OperåScope™ with HDMI cable & LCD intended for hysteroscopy and cystoscopy FDA UDI
- Model / Reference
- OP-201-6 FDA UDI
- Description
- LiNA OperåScope™ with HDMI cable & LCD intended for hysteroscopy and cystoscopy FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05708265012398 FDA UDI
- FDA Product Code
- HIH FDA UDIFAJ FDA UDI
- GMDN Term
- Rigid video hysteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
LiNA OperåScope™ with HDMI cable & LCD by Lina Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lina Medical ApS
Sources (1)
- FDA UDI 37582daa-c9b6-45ad-b251-6327a9e4d9c3 35 fields · synced May 30, 2026