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Chlamydia Antigen Rapid Test Kit
EUDAMEDClass C (EU MDR)
Ref ICH-502Model Cassette
Identity
- Trade Name
- Chlamydia Antigen Rapid Test Kit EUDAMED
- Device Name
- Chlamydia Antigen Rapid Test Kit EUDAMED
- Model / Reference
- Cassette EUDAMEDICH-502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972412610129 EUDAMED
- Basic UDI-DI
- 697241261ICH-50295 EUDAMED
- EMDN Code
- W0105090101 CHLAMYDIA AG - RT & POC EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Chlamydia 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 | 697241261ICH-50295 | 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 0436eafa-2387-4265-b759-9a97687ad4e2 61 fields · synced Jul 30, 2026