Identity
- Trade Name
- Sim.CAM HD WIRELESS 10x complete FDA UDI
- Generic Name
- Surgical video camera FDA UDI
- Device Name
- SET Sim.CAM HD WIRELESS 10-times camera, reuseable handle, receiver, remote control, receiver mounting SET and cables FDA UDI
- Model / Reference
- 141-0019063 SET FDA UDI
- Description
- SET Sim.CAM HD WIRELESS 10-times camera, reuseable handle, receiver, remote control, receiver mounting SET and cables FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250613846427 FDA UDI
- FDA Product Code
- KQM FDA UDI
- GMDN Term
- Surgical video camera FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4160 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: Surgical video camera
Sim.CAM HD WIRELESS 10x complete by S.I.M.E.O.N. Medical GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical video camera.
- Procam HD II — Ecleris · Class I
- Accu-Beam — Transamerican Technologies International · Class I
- Disposable cover_35x100_wide — GOOD DOCTORS CO., LTD. · Class I
- Pharos HD CCU — LONG ISLAND TECH · Class I
- PROCAM PACK — Ecleris · Class I
- FireCam HD Intraoral Camera — DIGIRAY Corp. · Class I
- Procam HD CMOS II CONSOLE — Ecleris · Class I
- PROCAM Basic PAL — Ecleris · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S.I.M.E.O.N. Medical GmbH & Co. KG
Sources (1)
- FDA UDI 45ad5ebb-750b-45dd-8b62-baf723847d4e 33 fields · synced May 30, 2026