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Chlamydia Trachomatis Test
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref R16-110Ref R16-112
Identity
- Device Name
- Chlamydia Trachomatis Test EUDAMED
- Model / Reference
- R16-110 EUDAMEDR16-112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571816017 EUDAMED06941571816024 EUDAMED
- Basic UDI-DI
- B-06941571816017 EUDAMEDB-06941571816024 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
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
Chlamydia Trachomatis Test by Ameritech Diagnostic Reagent (Jiaxing) 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-06941571816017 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020607
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 9d4ebea7-3c4d-4c37-a08f-add37c22b77c 61 fields · synced Jul 12, 2026
- EUDAMED 16ed4cbd-6dbd-4fd8-b61b-c1d21cde5eb8 61 fields · synced May 18, 2026