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Gastric Function Triple Test Kit (QDs-FICA)

by Chongqing Juce Life Health Technology Co., Ltd. China EUDAMED

Ref CB0301Model Specification 1: Pepsinogen I, Pepsinogen II, Gastrin-17 Specification 2: Pepsinogen I, Pepsinogen II Each specification includes 1 pcs/box, 5 pcs/box, 10 pcs/box, 50 pcs/box, and 100 pcs/box. EMDN W01010499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977981880300 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Specification 1: Pepsinogen I, Pepsinogen II, Gastrin-17 Specification 2: Pepsinogen I, Pepsinogen II Each specification includes 1 pcs/box, 5 pcs/box, 10 pcs/box, 50 pcs/box, and 100 pcs/box., CB0301
Primary DI / UDI-DI
06977981880300
Basic UDI-DI
B-06977981880300
EMDN Code
W01010499 Multiple clin. chem lab reagents - other
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000053774
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Chongqing Juce Life Health Technology Co., Ltd.

See all devices from Chongqing Juce Life Health Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED e23720bd-0cb4-4078-972b-74127431146a 61 fields · synced 23 Oct 2026