Identity
- Trade Name
- SupraSperm System FDA UDI
- Generic Name
- IVF medium kit FDA UDI
- Device Name
- SupraSperm System. 55% + 80% gradients. 2x10 ml FDA UDI
- Model / Reference
- 10922010D FDA UDI
- Description
- SupraSperm System. 55% + 80% gradients. 2x10 ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937801103 FDA UDI
- 510(k) Number
- K003404 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: IVF medium kit
SupraSperm System by Origio A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as IVF medium kit.
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- Vitrification Media(VS solution) — KITAZATO CORPORATION · Class II
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Cleared under the same submission
K003404 also covers:
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
- Origio A/S
Sources (1)
- FDA UDI 4051d13b-fb49-4f26-991e-75a9210987b5 35 fields · synced May 30, 2026