Identity
- Trade Name
- PureSperm Buffer EUDAMEDNidacon FDA UDI
- Generic Name
- Spermatozoa/semen motility medium supplement FDA UDI
- Device Name
- PurSperm Buffer EUDAMEDThe product is intended to be used for diluting PureSperm® sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®. FDA UDI
- Model / Reference
- PSB-100 EUDAMEDPureSperm® Buffer FDA UDI
- Description
- The product is intended to be used for diluting PureSperm® sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®. FDA UDI
Identifiers
- Catalog Number
- PSB-100 FDA UDI
- Primary DI / UDI-DI
- 07350025610061 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07350025610061 EUDAMED
- 510(k) Number
- K011606 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
No
EUDAMED
Human Tissues
No
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 Buffer 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011606 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-07350025610061 | Class III | Active |
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Manufacturer
- Manufacturer
- Nidacon International AB
- EUDAMED SRN
- SE-MF-000001933
Sources (3)
- EUDAMED 1b08b182-fef6-4cd6-b509-4c05db7d52aa 61 fields · synced Jun 19, 2026
- FDA UDI 45c19372-c78b-4fb3-b56b-51ad52a0c289 37 fields · synced May 30, 2026
- FDA 510(k) K011606 1 fields · synced May 18, 2026