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Angiotensin Converting Enzyme (ACE) Test Kit (Colorimetric)

by Biobase Biodustry(Shandong) Co., Ltd. China EUDAMEDGUDID

Ref R:60mL×2（701） Product code KQNEMDN W01010109

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-06971674866831 Basic UDI-DIDate27 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971674866831 UDI-DIDate22 Jul 2023ListedStatusIn 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 AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDD Expiring
  • 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
Angiotensin Converting Enzyme (ACE) Test Kit (Colorimetric) EUDAMED
Biobase GUDID
Generic Name
Angiotensin converting enzyme (ACE) IVD, reagent
Model / Reference
R:60mL×2（701） EUDAMED
R:60mL×2 GUDID
Primary DI / UDI-DI
06971674866831
Basic UDI-DI
B-06971674866831
FDA Product Code
KQN
EMDN Code
W01010109 Angiotensin converting enzyme (cc)
GMDN Term
Angiotensin converting enzyme (ACE) IVD, reagent
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.1090
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
R:60mL×2（701）
GUDID
R:60mL×2
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000025015
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (15)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No

Sources (2)

  • EUDAMED f3c46599-5531-4729-b303-843e41196a9e 61 fields · synced 22 Oct 2026
  • FDA UDI b5b8ba41-645d-4378-bea5-9667eeae4a76 32 fields · synced 30 May 2026