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Respiratory Pathogens Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref KS625-HXDB24Model Specification B: 8 tests/strip,24 tests/box
Identity
- Trade Name
- Respiratory Pathogens Detection Kit EUDAMED
- Device Name
- Respiratory Pathogens Detection Kit EUDAMED
- Model / Reference
- Specification B: 8 tests/strip,24 tests/box EUDAMEDKS625-HXDB24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974987420097 EUDAMED
- Basic UDI-DI
- B-06974987420097 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX 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
Respiratory Pathogens Detection Kit by Guangzhou KingCreate Biotechnology 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-06974987420097 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou KingCreate Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000032033
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 35d18ee8-67ca-423e-8c18-f733c6489809 61 fields · synced Jun 18, 2026