Identity
- Trade Name
- MedGyn IUI FDA UDI
- Generic Name
- Sperm filtration system FDA UDI
- Device Name
- iui mini curved FDA UDI
- Model / Reference
- mini curved FDA UDI
- Description
- iui mini curved FDA UDI
Identifiers
- Catalog Number
- 022725 FDA UDI
- Primary DI / UDI-DI
- M803022725 FDA UDI
- FDA Product Code
- MQF FDA UDI
- GMDN Term
- Sperm filtration system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6110 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
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
MR Safe FDA UDI
Category: Sperm filtration system
MedGyn IUI by Medgyn Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sperm filtration system.
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- RI MSC — Research Instruments , Ltd. · 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
- Medgyn Products, Inc.
Sources (1)
- FDA UDI 968704f2-d67b-44b7-84c9-a02dd3565449 34 fields · synced May 30, 2026