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Cartridges for the Blood gas & Electrolyte analyzer（Dry Electrolyte Chemistry)

by Chengdu Polytech Biological Technology Co., Ltd. 5 variants

Ref MD10499Model BG8

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975429090007 Basic UDI-DI 06975429090007UDI-DIDate28 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
BG8, MD10499
Primary DI / UDI-DI
06975429090007
Basic UDI-DI
B-06975429090007
EMDN Code
W0101060609 Blood gas incl. electrolytes / metabolites - unitary use cassette
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000034373
Authorised representative
GRZAN GROUP SL ES-AR-000039086

Other devices from Chengdu Polytech Biological Technology Co., Ltd.

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Surgical Instrument: No