Identity
- Trade Name
- Nidacon FDA UDI
- Generic Name
- Spermatozoa/semen motility medium supplement FDA UDI
- Device Name
- The product is intended to be used as an accessory for the separation and purification of human spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for IntraUterine Insemination (IUI) and for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies FDA UDI
- Model / Reference
- PureSperm® Wash FDA UDI
- Description
- The product is intended to be used as an accessory for the separation and purification of human spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for IntraUterine Insemination (IUI) and for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies FDA UDI
Identifiers
- Catalog Number
- PSW-035 FDA UDI
- Primary DI / UDI-DI
- 07350025610085 FDA UDI
- 510(k) Number
- K002630 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- Spermatozoa/semen motility medium supplement 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
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
No
FDA UDI
Category: Spermatozoa/semen motility medium supplement
Nidacon by Nidacon International AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spermatozoa/semen motility medium supplement.
- SpermSelect Mini Kit — CooperSurgical, Inc. · Class II
- Enhance Sperm Wash with Gentamicin — Vitrolife AB · Class II
- Enhance-S Plus — Vitrolife AB · Class II
- Enhance-S Plus — Vitrolife AB · Class II
- Enhance Sperm Wash w/ Gentamicin — Vitrolife AB · Class II
- Enhance-S Plus — Vitrolife AB · Class II
- Enhance-S Plus — Vitrolife AB · Class II
- SpermSelect Curve Kit — CooperSurgical, Inc. · Class II
Cleared under the same submission
K002630 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 |
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Manufacturer
- Manufacturer
- Nidacon International AB
Sources (1)
- FDA UDI 6dd0d909-3105-4821-bece-3e652d85a20e 37 fields · synced May 30, 2026