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Typhoid IgG/IgM Rapid Test Strip (whole blood +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref A100501SRef TYP-4022
Identity
- Trade Name
- Typhoid IgG/IgM Rapid Test Strip(whole blood/serum/plasma) EUDAMEDTyphoid IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) EUDAMED
- Device Name
- Typhoid IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) EUDAMED
- Model / Reference
- A100501S EUDAMEDTYP-4022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753472712 EUDAMEDD-697424646TYP003UQGN EUDAMED
- Basic UDI-DI
- B-06976753472712 EUDAMEDB-697424646TYP003UQGN EUDAMED
- EMDN Code
- W0105011799 BACTERIOLOGY IMMUNOASSAY - OTHER EUDAMEDW0105090199 BACTERIOLOGY - RT & POC - OTHER EUDAMED
- Models / Variants
- whole blood EUDAMEDserum EUDAMEDplasma EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
Typhoid IgG/IgM Rapid Test Strip (whole blood +2 more) by Hangzhou Cybereagen Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 3 models
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-06976753472712 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Cybereagen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000037850
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 858f5fe9-ea07-4ccf-9836-90a69b8ff8ba 61 fields · synced Oct 5, 2026
- EUDAMED 0826407a-4a82-44c4-9e8c-70b09580a96e 61 fields · synced Jul 29, 2026