GI Bacteria Controls

by Zhejiang Orient Gene Biotech Co., Ltd China EUDAMED

Ref CGIBACZK01-AOG4E

EMDN W0105080808

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-CGIBACZK01-AOGVH Basic UDI-DI	Date14 Sep 2026Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: GI Bacteria Controls
Model / Reference: CGIBACZK01-AOG4E

Primary DI / UDI-DI: D-CGIBACZK01-AOGVH
Basic UDI-DI: B-CGIBACZK01-AOGVH
EMDN Code: W0105080808 All infectious diseases controls - nat

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000017965
Authorised representative: CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties & raw data

Show properties, registry sources and raw records

Microbial Substances
Reagent
Professional Testing

Other properties (7)

Sterile: No
Human Tissues: No
Animal Tissues: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED D-CGIBACZK01-AOGVH|B-CGIBACZK01-AOGVH 61 fields · synced 24 Oct 2026