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PureSperm Buffer

by Nidacon International AB

Ref PSB-100

PureSperm Buffer (PSB-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 15 Jun 2022 (Basic UDI-DI B-07350025610061), cleared under FDA 510(k) K011606 on 12 Jul 2001 and listed in FDA GUDID since 15 Dec 2017 (UDI-DI 07350025610061), 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) K011606↗

FDA record

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-07350025610061 Basic UDI-DI 07350025610061UDI-DIDate15 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07350025610061 UDI-DI Date15 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK011606 Date12 Jul 2001IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07350025610061 registered 15 Jun 2022 Active
  • FDA 510(k) K011606 decided 12 Jul 2001 Active
  • FDA GUDID UDI-DI 07350025610061 listed 15 Dec 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K011606
  2. Listed FDA GUDID 07350025610061
  3. Registered EUDAMED B-07350025610061

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  • Withdrawn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 Buffer EUDAMED
Nidacon GUDID
Generic name
Spermatozoa/semen motility medium supplement
Device name
PurSperm Buffer
Model / Ref / Catalog
PSB-100, PureSperm® Buffer
Primary DI / UDI-DI
07350025610061
Basic UDI-DI
B-07350025610061
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
PSB-100
GUDID
PureSperm® Buffer
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)