Identity
- Trade Name
- Bioseal Inc. FDA UDI
- Generic Name
- Fibreoptic vaginal speculum FDA UDI
- Device Name
- Vaginal Speculum Clear X-Small, Light Source FDA UDI
- Model / Reference
- KI801/20 FDA UDI
- Description
- Vaginal Speculum Clear X-Small, Light Source FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630094298016 FDA UDI
- FDA Product Code
- HIC FDA UDI
- GMDN Term
- Fibreoptic vaginal speculum FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fibreoptic vaginal speculum
Bioseal Inc. by Bioseal — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibreoptic vaginal speculum.
- Bioseal Inc. — BIOSEAL · Class II
- Bioseal Inc. — BIOSEAL · Class II
- Bioseal Inc. — BIOSEAL · Class II
- Bioseal Inc. — BIOSEAL · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioseal
Sources (1)
- FDA UDI 5fc63392-141d-48cc-b489-e1ce825d77d1 33 fields · synced May 31, 2026