← Back to catalogue
Trichomonas Ag Rapid Test Cassette (Swab)
EUDAMEDClass IVD General (EU MDR)
Ref GCTV-502a
Identity
- Trade Name
- Trichomonas Ag Rapid Test Cassette (Swab) EUDAMED
- Device Name
- Trichomonas Ag Rapid Test Cassette (Swab) EUDAMED
- Model / Reference
- GCTV-502a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCTV-502a9Z EUDAMED
- Basic UDI-DI
- B-GCTV-502a9Z EUDAMED
- EMDN Code
- W0105050210 TRICHOMONAS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Trichomonas Ag Rapid Test Cassette (Swab) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-GCTV-502a9Z | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED bb123326-6816-4627-863e-9413945f8dea 61 fields · synced Oct 8, 2026