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XPER Technology Lactate Monitoring System L1

by Taidoc Technology Corporation

Ref TD-4261

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

CE IVDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-04719893239003 Basic UDI-DI 04719893239003UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719893239003 UDI-DI Date3 Aug 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  • Withdrawn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/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
XPER Technology L1 EUDAMED
XPER Technology Lactate Monitoring System L1 GUDID
Generic Name
Lactate IVD, reagent
Device Name
Lactate Monitoring System
Model / Reference
TD-4261 EUDAMED
L1 GUDID
Primary DI / UDI-DI
04719893239003
Basic UDI-DI
B-04719893239003
FDA Product Code
KHP
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
GMDN Term
Lactate IVD, reagent
Device Class
Class IVD Annex II List B EUDAMED
Class I GUDID
Regulation Number
862.1450
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
TD-4261
GUDID
L1
Device ClassEUDAMED
Class IVD Annex II List B
GUDID
Class I

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Properties

  • Self Testing
  • Professional Testing
  • Surgical Instrument
  • Premarket Exempt
  • Serial Number

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No