← Back to catalogue
Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA)
EUDAMEDClass IVD General (EU MDR)
Ref C2KJ003Ref C2KC003
Identity
- Trade Name
- Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA) EUDAMED
- Model / Reference
- C2KJ003 EUDAMEDC2KC003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792053458 EUDAMED06976753477588 EUDAMED
- Basic UDI-DI
- B-06971792053458 EUDAMEDB-06976753477588 EUDAMED
- EMDN Code
- W0105050209 PLASMODIUM (MALARIA) 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
Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA) by Hangzhou Realy Tech 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-06971792053458 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED c144e5ce-93c0-4550-946b-2bec54fdbc36 61 fields · synced Oct 6, 2026
- EUDAMED d89c7388-382b-444b-9c47-ef9bc1e6e74d 61 fields · synced May 18, 2026