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Multichem hsTn HS301MX

by Techno-Path Manufacturing

Ref HS301MX

Multichem hsTn HS301MX is a device classified as Class C in the EU and Class I in the US made by Techno-Path Manufacturing, registered in EUDAMED on 10 Aug 2026 (Basic UDI-DI 539152344IMMA019A) and listed in FDA GUDID since 16 Sep 2022 (UDI-DI 05391523441179), active as of 24 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number539152344IMMA019A Basic UDI-DI 05391523441179UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05391523441179 UDI-DI Date16 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 539152344IMMA019A registered 10 Aug 2026 Active
  • FDA GUDID UDI-DI 05391523441179 listed 16 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05391523441179
  2. Registered EUDAMED 539152344IMMA019A

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  • Withdrawn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
Multichem hsTn
Generic name
Multiple-type clinical chemistry analyte profile IVD, control
Model / Ref / Catalog
HS301MX
Primary DI / UDI-DI
05391523441179
Basic UDI-DI
539152344IMMA019A
FDA product code
JJY, OHQ
EMDN code
W0102152004 Cardiac marker controls
GMDN term
Multiple-type clinical chemistry analyte profile IVD, control
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Standard device
EU 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

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

Related devices

Category: Multiple-type clinical chemistry analyte profile IVD, control

Similar devices in this category

Other devices filed under CARDIAC MARKER CONTROLS.

Other devices from Techno-Path Manufacturing

See all devices from Techno-Path Manufacturing →

Properties

  • Contains human tissues or cells
  • Contains substances of microbial origin
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)