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ICSI Pipette 15653

by Vitrolife Sweden AB

Part of a family of 139 devices: see the family page

Ref 15653

ICSI Pipette 15653 is a device classified as Class I in the EU and Class II in the US made by Vitrolife Sweden AB, registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI 735002591ACADG) and listed in FDA GUDID since 9 Dec 2022 (UDI-DI 17350025918560), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735002591ACADG Basic UDI-DI 17350025918560UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17350025918560 UDI-DI Date9 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 735002591ACADG registered 30 Jun 2026 Active
  • FDA GUDID UDI-DI 17350025918560 listed 9 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 17350025918560
  2. Registered EUDAMED 735002591ACADG

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ICSI Pipette
Generic name
User-induced micropipette
Device name
Micromanipulation Pipettes
Model / reference
15653
Primary DI / UDI-DI
17350025918560
Basic UDI-DI
735002591ACADG
FDA product code
PUC
EMDN code
U0802030106 Icsi pipettes
GMDN term
User-induced micropipette
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.6130
EU registration type
Standard device
EU market of registration
Sweden
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: User-induced micropipette

Similar devices in this category

Other devices filed under PIPETTES FOR ASSISTED REPRODUCTION.

Other devices from Vitrolife Sweden AB

See all devices from Vitrolife Sweden AB →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)