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RADI Kala-azar (Leishmania) Detection KIT
EUDAMEDClass IVD General (EU MDR)
Ref RB003
Identity
- Device Name
- RADI Kala-azar (Leishmania) Detection KIT EUDAMED
- Model / Reference
- RB003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800204300263 EUDAMED
- Basic UDI-DI
- B-08800204300263 EUDAMED
- EMDN Code
- W0105050205 LEISHMANIA 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
RADI Kala-azar (Leishmania) Detection KIT by KH Medical Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-08800204300263 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- KH Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000017883
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 799d5fc6-7335-4098-b375-93021cc0249c 61 fields · synced Jul 22, 2026