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13C & Hydrogen Breath Analyzer

by Guangzhou Richen-Frinse Optical &Electronic Co., Ltd.

Ref CH02Model 13C/H2-BTF

Active European Union

CE IVDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697242624CH02EV Basic UDI-DI 06972426240275UDI-DIDate24 Jan 2024RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
13C & Hydrogen Breath Analyzer
Model / Reference
13C/H2-BTF, CH02
Primary DI / UDI-DI
06972426240275
Basic UDI-DI
697242624CH02EV
Direct Marketing DI
06972426240275
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000029615
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Guangzhou Richen-Frinse Optical &Electronic Co., Ltd.

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No