Identity
- Trade Name
- PureSperm Wash EUDAMEDNidacon FDA UDI
- Generic Name
- Spermatozoa/semen motility medium supplement FDA UDI
- Device Name
- PureSperm Wash EUDAMEDThe 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
- PSW-100 EUDAMEDPureSperm® 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-100 FDA UDI
- Primary DI / UDI-DI
- 07350025610078 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07350025610078 EUDAMED
- 510(k) Number
- K002630 FDA UDI
- FDA Product Code
- MQL FDA UDI
- EMDN Code
- U08020502 MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- Spermatozoa/semen motility medium supplement FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
Yes
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
PureSperm Wash by Nidacon International Ab — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002630 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K980814 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-07350025610078 | Class III | Active |
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Manufacturer
- Manufacturer
- Nidacon International AB
- EUDAMED SRN
- SE-MF-000001933
Sources (3)
- EUDAMED 37a156fd-244b-43a6-89a5-472ccaa5c705 61 fields · synced Jul 20, 2026
- FDA UDI 37195e63-8652-44c8-bd8e-32636ba559db 37 fields · synced May 30, 2026
- FDA 510(k) K002630 1 fields · synced May 18, 2026