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Chlamydia and Gonorrhea Antigen Rapid Test Kit
EUDAMEDClass C (EU MDR)
Ref IGC-525Model Cassette
Identity
- Device Name
- Chlamydia and Gonorrhea Antigen Rapid Test Kit EUDAMED
- Model / Reference
- Cassette EUDAMEDIGC-525 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972412611799 EUDAMED
- Basic UDI-DI
- 697241261IGC-5259E EUDAMED
- EMDN Code
- W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Chlamydia and Gonorrhea Antigen Rapid Test Kit by Hangzhou Laihe Biotech Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697241261IGC-5259E | Class C | Active |
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Manufacturer
- Manufacturer
- Hangzhou Laihe Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000033566
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 4c7b13dc-16e7-4070-b310-325942406cbe 61 fields · synced Jun 20, 2026