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PureSperm 40

by Nidacon International AB

Ref PS40-100

PureSperm 40 (PS40-100) 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 14 Jun 2022 (Basic UDI-DI B-07350025610016), cleared under FDA 510(k) K002623 on 20 Nov 2000 and listed in FDA GUDID since 15 Dec 2017 (UDI-DI 07350025610016), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K002623

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07350025610016 Basic UDI-DI 07350025610016UDI-DIDate14 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07350025610016 UDI-DI Date15 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK002623 Date20 Nov 2000DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07350025610016 registered 14 Jun 2022 Active
  • FDA 510(k) K002623 decided 20 Nov 2000 Active
  • FDA GUDID UDI-DI 07350025610016 listed 15 Dec 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K002623
  2. Listed FDA GUDID 07350025610016
  3. Registered EUDAMED B-07350025610016

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
PureSperm 40 EUDAMED
Nidacon GUDID
Generic name
Spermatozoa/semen motility medium supplement
Model / Ref / Catalog
PS40-100, PureSperm® 40
Primary DI / UDI-DI
07350025610016
Basic UDI-DI
B-07350025610016
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
PS40-100
GUDID
PureSperm® 40
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
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)