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Enterohemorrhagic Escherichia coli Nucleic Acid Detection Kit (Fluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref Fa019
Identity
- Device Name
- Enterohemorrhagic Escherichia coli Nucleic Acid Detection Kit (Fluorescence) EUDAMED
- Model / Reference
- Fa019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697994388Fa019WN8S EUDAMED
- Basic UDI-DI
- B-697994388Fa019WN8S EUDAMED
- EMDN Code
- W0105011699 BACTERIOLOGY - NA REAGENTS - OTHER 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
Enterohemorrhagic Escherichia coli Nucleic Acid Detection Kit (Fluorescence) 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-697994388Fa019WN8S | 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 3fed5f44-3f26-4c50-ada7-7e35f5a62bb5 61 fields · synced Sep 30, 2026