Identity
- Trade Name
- Gynius FDA UDI
- Generic Name
- Colposcope FDA UDI
- Device Name
- The Gynocular is a colposcope intended to provide magnified visualization for the tissues of the vagina, cervix and the external genitalia. It Is used to evaluate these tissues and select areas for biopsy. FDA UDI
- Model / Reference
- V1 FDA UDI
- Description
- The Gynocular is a colposcope intended to provide magnified visualization for the tissues of the vagina, cervix and the external genitalia. It Is used to evaluate these tissues and select areas for biopsy. FDA UDI
Identifiers
- Catalog Number
- GYN-0001 FDA UDI
- Primary DI / UDI-DI
- 07300009046461 FDA UDI
- FDA Product Code
- HEX 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Colposcope
Gynius by Gynius AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colposcope.
- MICROSCOPE Colposcope — Ecleris · Class II
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- 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
- Gynius AB
Sources (1)
- FDA UDI e9e4cc64-ccd7-4bdc-bf8b-1072b4f7752a 36 fields · synced May 30, 2026