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Controls

by Edan Instruments, Inc. China EUDAMEDGUDID

Ref Blood Gas and Electrolyte Control Level 3, Blood Gas and Electrolyte Control Level 2

Product code JJSEMDN W0101050204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-06944413847538 Basic UDI-DIDate4 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413847538 UDI-DIDate1 Sep 2016ListedStatusIn 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/IVDD Expiring (legacy directive)
  • 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
Controls EUDAMED
Blood Gas and Electrolyte Control GUDID
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Model / Reference
Blood Gas and Electrolyte Control Level 3 EUDAMED
Blood Gas and Electrolyte Control Level 2 EUDAMED
Level 2 GUDID
Primary DI / UDI-DI
06944413847538, 06944413801998, 06944413815582, 06944413815599, 06944413809093
Basic UDI-DI
B-06944413847538, B-06944413815582, B-06944413815599, B-06944413801998, B-06944413809093
510(k) Number
FDA Product Code
JJS
EMDN Code
W0101050204 Electrolyte controls
GMDN Term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
862.1660
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Blood Gas and Electrolyte Control Level 3
Blood Gas and Electrolyte Control Level 2
GUDID
Level 2
Device ClassEUDAMED
Class IVD General
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000009957
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (14)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No

Sources (6)

  • EUDAMED c11afc90-708f-48df-8bb4-04f50242289b 61 fields · synced 22 Oct 2026
  • FDA UDI df245040-99f9-4ba2-959f-ca8525ae3f11 33 fields · synced 30 May 2026
  • EUDAMED 06944413815582|B-06944413815582 61 fields · synced 10 Jul 2026
  • EUDAMED 06944413815599|B-06944413815599 61 fields · synced 30 Jul 2026
  • EUDAMED 06944413801998|B-06944413801998 61 fields · synced 1 Aug 2026
  • EUDAMED 06944413809093|B-06944413809093 61 fields · synced 15 Oct 2026