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Ease-Eject Sampler

by Advanced Instruments, LLC

Ref 3M0825

Ease-Eject Sampler (3M0825) is a mechanical pipette (EU IVDR Class A; FDA Class I; FDA product code JJM, Osmometer For Clinical Use) made by Advanced Instruments, LLC, registered in EUDAMED on 23 Nov 2022 (Basic UDI-DI 081606802OSMOACCSY5) and listed in FDA GUDID since 21 Sep 2020 (UDI-DI 00816068020504), active as of 22 Oct 2026.

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

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081606802OSMOACCSY5 Basic UDI-DI 00816068020504UDI-DIDate23 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00816068020504 UDI-DI Date21 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081606802OSMOACCSY5 registered 23 Nov 2022 Active
  • FDA GUDID UDI-DI 00816068020504 listed 21 Sep 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00816068020504
  2. Registered EUDAMED 081606802OSMOACCSY5

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Ease-Eject Sampler EUDAMED
Advanced Instruments Ease-Eject 20-Microliter Sampler GUDID
Generic name
Mechanical pipette
Device name
Osmometer Accessories
Model / Ref / Catalog
3M0825
Primary DI / UDI-DI
00816068020504
Basic UDI-DI
081606802OSMOACCSY5
FDA product code
JJM
EMDN code
W0503020199 Pipettes - other
GMDN term
Mechanical pipette
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2730
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
US-MF-000027205
Authorised representative
WMDE B.V. NL-AR-000002062

Similar devices in this category

Other devices filed under PIPETTES.

Other devices from Advanced Instruments, LLC

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Properties

  • Single use
  • Professional testing
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)