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Pneumocystis jirovecii Nucleic Acid Detection Kit (Fluorescence, BALF)
EUDAMEDClass IVD General (EU MDR)
Ref Fa045
Identity
- Device Name
- Pneumocystis jirovecii Nucleic Acid Detection Kit (Fluorescence, BALF) EUDAMED
- Model / Reference
- Fa045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697994388Fa045WP8X EUDAMED
- Basic UDI-DI
- B-697994388Fa045WP8X EUDAMED
- EMDN Code
- W0105060405 PNEUMOCYSTIS - NA REAGENTS 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
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
Pneumocystis jirovecii Nucleic Acid Detection Kit (Fluorescence, BALF) by Kangsheng Information Technology (Hangzhou) Co. LTD — Class IVD General — 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-697994388Fa045WP8X | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kangsheng Information Technology (Hangzhou) Co. LTD
- EUDAMED SRN
- CN-MF-000053775
- Authorised Representative
- Crealkraft GmbH DE-AR-000049943
Sources (1)
- EUDAMED b35a3257-3eaf-4a59-ba74-ac6ab717c2e3 61 fields · synced Jun 19, 2026