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Stripper MXL3-Str

by Origio Inc.

Ref MXL3-STR

Stripper MXL3-Str is a device classified as Class I in the EU and Class II in the US made by Origio Inc., registered in EUDAMED on 6 May 2026 (Basic UDI-DI B-00888937907872), cleared under FDA 510(k) K993699 on 16 May 2000 and listed in FDA GUDID since 22 Aug 2016 (UDI-DI 00888937907872), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K993699

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00888937907872 Basic UDI-DI 00888937907872UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888937907872 UDI-DI Date22 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK993699 Date16 May 2000DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00888937907872 registered 6 May 2026 Active
  • FDA 510(k) K993699 decided 16 May 2000 Active
  • FDA GUDID UDI-DI 00888937907872 listed 22 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K993699
  2. Listed FDA GUDID 00888937907872
  3. Registered EUDAMED B-00888937907872

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  • Withdrawn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
Generic name
Assisted reproduction microtool
Device name
The STRIPPER® Micropipetter
Model / reference
MXL3-STR
Primary DI / UDI-DI
00888937907872
Basic UDI-DI
B-00888937907872
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 (K993699)

and 8 more cleared under K993699

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)