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Diagnostic Kit for Human IgM Antibody of Chlamydia Pneumoniae (Immunochromatogr…
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref W135-C
Identity
- Device Name
- Diagnostic Kit for Human IgM Antibody of Chlamydia Pneumoniae (Immunochromatographic Assay) EUDAMED
- Model / Reference
- W135-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-W135-C4U EUDAMED
- Basic UDI-DI
- B-W135-C4U EUDAMED
- EMDN Code
- W0105010116 CHLAMYDIA PNEUMONIAE ANTIBODY IGM EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Italy 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
Diagnostic Kit for Human IgM Antibody of Chlamydia Pneumoniae (Immunochromatogr… by Guangzhou Wondfo Biotech Co., Ltd. — Class IVD Annex II List B — IVDD…
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-W135-C4U | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000000689
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED b5108974-e43f-49db-8fa3-a00fca570e84 61 fields · synced Jul 21, 2026