Skip to content

Microvials

by M Dialysis AB Sweden EUDAMEDGUDID

Ref P000154

Product code GWMEMDN W050180

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number7332699_330_007_X6 Basic UDI-DIDate26 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07332699000645 UDI-DIDate24 Sep 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Microvials in rack, Sterile 12x4
Generic Name
Microdialysis system
Device Name
Microvials
Model / Ref / Catalog
P000154, Sterile
Primary DI / UDI-DI
07332699000645
Basic UDI-DI
7332699_330_007_X6
Unit of Use DI
07332699000980
FDA Product Code
GWM
EMDN Code
W050180 Samples collection devices - other accessories
GMDN Term
Microdialysis system
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
882.1620
Market of Registration
Sweden
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
P000154
GUDID
Sterile
Device ClassEUDAMED
Class A
GUDID
Class II

Manufacturer details

EUDAMED SRN
SE-MF-000017466

Other devices from M Dialysis AB

See all devices from M Dialysis AB →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Human Tissues
  • Microbial Substances
  • Near-Patient Testing
  • Lot / Batch Number
  • Expiration Date
Other properties (17)
  • Implantable: No
  • Contains Latex: No
  • Animal Tissues: No
  • Reagent: No
  • Self Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED c8fbb991-3ba6-4fe6-9d3a-2fc84e592417 61 fields · synced 22 Oct 2026
  • FDA UDI 9c9ce31b-631e-4387-ba17-0b44eeda4261 34 fields · synced 30 May 2026