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Stripper MXL3-Str-Pgd

by Origio Inc.

Ref MXL3-STR-PGD

Stripper MXL3-Str-Pgd is a device classified as Class I in the EU and Class II in the US made by Origio Inc., registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI B-00888937907933), cleared under FDA 510(k) K041435 on 29 Sep 2004 and listed in FDA GUDID since 22 Aug 2016 (UDI-DI 00888937907933), 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) K041435

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00888937907933 Basic UDI-DI 00888937907933UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888937907933 UDI-DI Date22 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK041435 Date29 Sep 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00888937907933 registered 21 Sep 2026 Active
  • FDA 510(k) K041435 decided 29 Sep 2004 Active
  • FDA GUDID UDI-DI 00888937907933 listed 22 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K041435
  2. Listed FDA GUDID 00888937907933
  3. Registered EUDAMED B-00888937907933

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  • Withdrawn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
Stripper® EUDAMED
Stripper GUDID
Generic name
Assisted reproduction microtool
Device name
The STRIPPER® PGD Micropipetter
Model / reference
MXL3-STR-PGD
Primary DI / UDI-DI
00888937907933
Basic UDI-DI
B-00888937907933
510(k) Number
FDA product code
MQH
EMDN code
U0802030102, U0802030103
GMDN term
Assisted reproduction microtool
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.6130
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Assisted reproduction microtool

Cleared under the same submission (K041435)

Similar devices in this category

Other devices filed under DEVICES FOR ASSISTED REPRODUCTION.

Other devices from Origio Inc.

See all devices from Origio Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (21, all answered No)