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PureSperm Wash

by Nidacon International AB 2 variants

Ref PSW-100

PureSperm Wash (PSW-100) is a spermatozoa/semen motility medium supplement (EU MDD Class III; FDA Class II; FDA product code MQL, Media, Reproductive) made by Nidacon International Ab, registered in EUDAMED on 16 Jun 2022 (Basic UDI-DI B-07350025610078), cleared under FDA 510(k) K002630 on 21 Nov 2000 (1 earlier submission) and listed in FDA GUDID since 15 Dec 2017 (UDI-DI 07350025610078), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K002630↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07350025610078 Basic UDI-DI 07350025610078UDI-DIDate16 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07350025610078 UDI-DI Date15 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK002630 Date21 Nov 2000IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07350025610078 registered 16 Jun 2022 Active
  • FDA 510(k) K002630 decided 21 Nov 2000 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07350025610078 listed 15 Dec 2017 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K980814
  2. Cleared FDA 510(k) K002630
  3. Listed FDA GUDID 07350025610078
  4. Registered EUDAMED B-07350025610078

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
PureSperm Wash EUDAMED
Nidacon GUDID
Generic name
Spermatozoa/semen motility medium supplement
Model / Ref / Catalog
PSW-100, PureSperm® Wash
Primary DI / UDI-DI
07350025610078
Basic UDI-DI
B-07350025610078
510(k) Number
FDA product code
MQL
EMDN code
U08020502 Materials/solutions for preparation/handling for assisted reproduction
GMDN term
Spermatozoa/semen motility medium supplement
Device class
Class III EUDAMED
Class II GUDID
Regulation number
884.6180
EU registration type
Legacy device (under a directive)
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PSW-100
GUDID
PureSperm® Wash
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
SE-MF-000001933

Similar devices in this category

Other devices filed under MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION.

Other devices from Nidacon International Ab

  • NidOil

    Class III

  • Proinsert

    Class II

  • Spermcatch

    Class II

  • Modification of Puresperm

    Class II

See all devices from Nidacon International Ab →

Properties

  • Supplied sterile
  • Incorporates a substance derived from human blood or plasma
  • Contains human tissues or cells
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)