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MycoMDx Pneumocystis jirovecii Cartridge PCR Assay
EUDAMEDClass IVD General (EU MDR)
Ref DNK-2605-2Model 48 tests/kit
Identity
- Device Name
- MycoMDx Pneumocystis jirovecii Cartridge PCR Assay EUDAMED
- Model / Reference
- 48 tests/kit EUDAMEDDNK-2605-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317807815 EUDAMED
- Basic UDI-DI
- B-06930317807815 EUDAMED
- EMDN Code
- W0105060405 PNEUMOCYSTIS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
MycoMDx Pneumocystis jirovecii Cartridge PCR Assay by Dynamiker Biotechnology (Tianjin) Co., Ltd. — Class IVD General — 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-06930317807815 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001133
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (1)
- EUDAMED 683ead66-de44-4af3-9e2c-3943d2908746 61 fields · synced Oct 6, 2026