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Sodium electrode

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMEDGUDID

Ref 040-000540-00

Product code JGSEMDN W0101070107

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number69449040SHYQ-200BNa****ZA Basic UDI-DIDate1 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06944904024622 UDI-DIDate23 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
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0920-2020 FDA Class II initiated 9 Dec 2019
    • Terminated Z-0921-2020 FDA Class II initiated 9 Dec 2019

    The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Sodium electrode EUDAMED
Na electrode,indirect,international GUDID
Generic Name
Sodium (Na+) electrode IVD
Model / Reference
040-000540-00
Primary DI / UDI-DI
06944904024622
Basic UDI-DI
69449040SHYQ-200BNa****ZA
510(k) Number
FDA Product Code
JGS
EMDN Code
W0101070107 Sodium - electrodes
GMDN Term
Sodium (Na+) electrode IVD
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.1665
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED dafe82a2-4a44-4af4-bc7e-cdf61e378e97 61 fields · synced 24 Oct 2026
  • FDA UDI 5e527662-408b-4904-a320-bbaf4a77e24b 34 fields · synced 30 May 2026