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Pathogen Multiplex-PCR Library Prep Kit
EUDAMEDClass A (EU MDR)
Ref AA03-01-96SRef AA03-01-96D
Identity
- Trade Name
- Pathogen Multiplex-PCR Library Prep Kit EUDAMED
- Device Name
- Pathogen Multiplex-PCR Library Prep Kit EUDAMED
- Model / Reference
- AA03-01-96S EUDAMEDAA03-01-96D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977805760023 EUDAMED06977805760160 EUDAMED
- Basic UDI-DI
- 697780576HSTAALIBTDZ EUDAMED697780576HSTAALIBGD7 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Pathogen Multiplex-PCR Library Prep Kit by Shenzhen Health SwifTech Co., Ltd. — Class A — 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 | 697780576HSTAALIBTDZ | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Health SwifTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000044339
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 72885ee2-8b12-4db7-84b9-d5c49d2c15fa 61 fields · synced Jul 13, 2026
- EUDAMED 7d796696-30e4-49bd-8093-c7864f8ca345 61 fields · synced May 17, 2026