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Micro-Sample Test Kit

by Advanced Instruments, LLC

Part of a family of 6 devices: see the family page

Ref 133800

Micro-Sample Test Kit (133800) is an osmolality IVD (EU IVDR Class A; FDA Class I; FDA product code JJM, Osmometer For Clinical Use) made by Advanced Instruments, LLC, registered in EUDAMED on 19 May 2023 (Basic UDI-DI 081606802SPECRECEPDL) and listed in FDA GUDID since 22 Mar 2019 (UDI-DI 00816068020498), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 Number081606802SPECRECEPDL Basic UDI-DI 00816068020498UDI-DIDate19 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00816068020498 UDI-DI Date22 Mar 2019ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081606802SPECRECEPDL registered 19 May 2023 Active
  • FDA GUDID UDI-DI 00816068020498 listed 22 Mar 2019 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 00816068020498
  2. Registered EUDAMED 081606802SPECRECEPDL

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  • Withdrawn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
Micro-Sample Test Kit EUDAMED
Advanced Instruments Microsample Test Kit, Plunger Wire, 500 Tips/Cleaners GUDID
Generic name
Osmolality IVD, kit, freezing point
Device name
Specimen Receptacles
Model / Ref / Catalog
133800
Primary DI / UDI-DI
00816068020498
Basic UDI-DI
081606802SPECRECEPDL
FDA product code
JJM
EMDN code
W02069085 Various sample processing instruments - consumables
GMDN term
Osmolality IVD, kit, freezing point
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
Not 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 VARIOUS SAMPLE PROCESSING INSTRUMENTS.

Other devices from Advanced Instruments, LLC

See all devices from Advanced Instruments, LLC →

Properties

  • Single use
  • Professional testing
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)