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Ammonia (AMM) Assay Kit (Glutamate Dehydrogenase Method)

by Yhlo Biotech (Nanjing) Co., Ltd. China EUDAMED

Ref 137H40TSC, 137H160TSC

EMDN W01010301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-137H40TSC5K Basic UDI-DIDate27 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
137H40TSC, 137H160TSC
Primary DI / UDI-DI
D-137H40TSC5K, D-137H160TSCNB
Basic UDI-DI
B-137H40TSC5K, B-137H160TSCNB
EMDN Code
W01010301 Ammonia
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000050474
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Yhlo Biotech (Nanjing) Co., Ltd.

See all devices from Yhlo Biotech (Nanjing) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 567cfefd-b296-42eb-9060-fe57ced4e746 61 fields · synced 22 Oct 2026
  • EUDAMED D-137H160TSCNB|B-137H160TSCNB 61 fields · synced 18 May 2026