MD Atlas
BlogPricingSign in
MD Atlas
Made In Tracker
Made In TrackerEasyUDI
Legal
Privacy PolicyLegal Notice
About
AboutFAQBlogPartnersContact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

  • MD Atlas
  • Zhejiang Orient Gene Biotech Co., Ltd

Data from EUDAMED, last updated Jun 11, 2026

V. cholerae O1/O139 Ag Combo Rapid Test Cassette (Feces)

B-GCVCH(O1/O9)-602aK7

1 reference

IVDD — General
Applicable legislation
IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category
IVDD — General
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd

Device family identification

Device name
V. cholerae O1/O139 Ag Combo Rapid Test Cassette (Feces)
Basic UDI-DI
B-GCVCH(O1/O9)-602aK7
Device model
GCVCH(O1/O9)-602a
Issuing agency
EUDAMED
Version date
May 11, 2026

Classification

Applicable legislation
IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category
IVDD — General
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
Zhejiang Orient Gene Biotech Co., Ltd
SRN
CN-MF-000017965
Country
China
Email
joyce.pang@orientgene.com

Authorised representative

Name
CMC Medical Devices & Drugs SL
SRN
ES-AR-000000293
Country
Spain
Phone
+34951214054

Device characteristics

ReagentProfessional testingAnimal tissues / cells

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

  • W0105011799Bacteriology immunoassay - other

References by status

Clinical investigations

Investigation number
TF- VCH(O1/O9) -B
Registered
No
Countries
China

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01KRB19NR7PGVAVVCA6C0W1VW8

Format

Summary

31 columns included
  • Trade name
  • Basic UDI-DI
  • UDI-DI code
  • Risk category
  • Applicable legislation
  • Status
  • Organization name
  • SRN
  • Reference / catalog number
  • Additional product description
  • Intended medical purpose
  • Market country
  • Issuing entity
  • Market info update date
  • Sterile
  • Single use
  • Contains latex
  • Reprocessed single-use
  • Direct marking
  • CMR substance
  • Endocrine disruptor
  • Annex XVI applicable
  • Sterilization
  • OEM applicable
  • EMDN codes
  • Last updated
  • Basic UDI-DI device name
  • Basic UDI-DI device model
  • Basic UDI-DI implantable
  • Basic UDI-DI reagent
  • DM Atlas link
Trade nameReference / catalog numberUDI-DI codeQuantityStatus
V. cholerae O1/O139 Ag Combo Rapid Test Cassette (Feces)GCVCH(O1/O9)-602aD-GCVCH(O1/O9)-602aK71On the market