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BIOBASE Control: 1mL×1

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

Ref 质控品：1mL×1（92012） Product code MSJEMDN W0102010404

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-06971674868255 Basic UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971674868255 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
Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric) EUDAMED
Biobase GUDID
Generic Name
Apolipoprotein E (Apo E) IVD, reagent
Model / Reference
质控品：1mL×1（92012） EUDAMED
Control: 1mL×1 GUDID
Primary DI / UDI-DI
06971674868255
Basic UDI-DI
B-06971674868255
FDA Product Code
MSJ
EMDN Code
W0102010404 Apolipoprotein e sub-typing
GMDN Term
Apolipoprotein E (Apo E) IVD, reagent
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
862.1475
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
质控品：1mL×1（92012）
GUDID
Control: 1mL×1
Device ClassEUDAMED
Class IVD General
GUDID
Class I

Related devices

Category: Apolipoprotein E (Apo E) IVD, reagent

Other devices from Biobase Biodustry(Shandong) Co., Ltd.

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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)

  • FDA UDI 6c2281b2-f45d-4dcf-9629-c01bba056f10 32 fields · synced 22 Oct 2026
  • EUDAMED 06971674868255|B-06971674868255 61 fields · synced 10 Jul 2026