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Multichem IA Set A

by Techno-path Manufacturing Ltd. 3 variants

Ref 10631759190

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

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number539152344IMMA109B Basic UDI-DI 05391523442619UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05391523442619 UDI-DI Date23 Mar 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Generic Name
Multiple-type clinical chemistry analyte profile IVD, control
Model / Ref / Catalog
10631759190
Primary DI / UDI-DI
05391523442619
Basic UDI-DI
539152344IMMA109B
FDA Product Code
JJY
EMDN Code
W0102152002 Hormone controls
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, control
Device Class
Class C EUDAMED
Class I GUDID
Regulation Number
862.1660
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class I

Manufacturer details

EUDAMED SRN
IE-MF-000001822

Other devices from Techno-Path Manufacturing

See all devices from Techno-Path Manufacturing →

Properties

  • Animal Tissues
  • Microbial Substances
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient 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
  • Manufacturing Date: No