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Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref /
Identity
- Trade Name
- Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold) EUDAMED
- Device Name
- Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935091671812 EUDAMED
- Basic UDI-DI
- B-06935091671812 EUDAMED
- EMDN Code
- W0105090101 CHLAMYDIA AG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Surgical Instrument
No
EUDAMED
Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold) by Qingdao Hightop Biotech Co., Ltd. — Class IVD Annex II List B — IVDD — listed in EUDAMED
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-06935091671812 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Qingdao Hightop Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000016890
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 6dbbc8f9-f884-42dd-8db4-885cf154a787 61 fields · synced Jun 18, 2026