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Gonorrhea Antigen Rapid Test Kit
EUDAMEDClass C (EU MDR)
Ref IGO-502Model Cassette
Identity
- Device Name
- Gonorrhea Antigen Rapid Test Kit EUDAMED
- Model / Reference
- Cassette EUDAMEDIGO-502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972412611782 EUDAMED
- Basic UDI-DI
- 697241261IGO-502D6 EUDAMED
- EMDN Code
- W0105010201 GONOCOCCAL ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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 | 697241261IGO-502D6 | 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 29a88c1c-ae1c-43bd-a58e-f770d3b04f54 61 fields · synced Jun 20, 2026