Identity
- Trade Name
- Cerviray FDA UDI
- Generic Name
- Colposcope FDA UDI
- Device Name
- The Cerviray is a handheld device that includes imaging optics, provides sequentially captured images of the cervix. The image can be viewed on the touch screen display. It typically consists of an illuminated lens and video camera unit connected to an LCD touch screen display. During use, Cerviray is used with the speculum(not provided) to keep a certain distance to obtain good quality of image and prevent direct contact with patient. The Cradle is also included for charging purpose only. FDA UDI
- Model / Reference
- ADT-CC10 FDA UDI
- Description
- The Cerviray is a handheld device that includes imaging optics, provides sequentially captured images of the cervix. The image can be viewed on the touch screen display. It typically consists of an illuminated lens and video camera unit connected to an LCD touch screen display. During use, Cerviray is used with the speculum(not provided) to keep a certain distance to obtain good quality of image and prevent direct contact with patient. The Cradle is also included for charging purpose only. FDA UDI
Identifiers
- Catalog Number
- D-23-090 FDA UDI
- Primary DI / UDI-DI
- 08800126000050 FDA UDI
- FDA Product Code
- PTZ FDA UDI
- GMDN Term
- Colposcope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1630 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
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
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: Colposcope
Cerviray by Aidot — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colposcope.
- MICROSCOPE Colposcope — Ecleris · Class II
- Bovie — BOVIE MEDICAL CORPORATION · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- MICROSTAR Colposcope — Ecleris · Class II
- Gynex — GYNEX CORPORATION · Class II
- MICROSCOPE Colposcope — Ecleris · Class II
- WALLACH — CooperSurgical, Inc. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
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
- Aidot
Sources (1)
- FDA UDI ace6b0bb-4660-469f-b1d5-bfa503bb3b08 35 fields · synced May 30, 2026