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Malaria Whole Blood (pv) Test
EUDAMEDClass IVD General (EU MDR)
Ref R11-110Ref R10-116
Identity
- Device Name
- Malaria Whole Blood (pv) Test EUDAMED
- Model / Reference
- R11-110 EUDAMEDR10-116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571811104 EUDAMED06941571810015 EUDAMED
- Basic UDI-DI
- B-06941571811104 EUDAMEDB-06941571810015 EUDAMED
- EMDN Code
- W0105090401 PLASMODIUM (MALARIA) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 Whole Blood (pv) Test by Ameritech Diagnostic Reagent (Jiaxing) 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-06941571811104 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020607
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 4a4228a1-e041-4886-a49a-8d7c466ccfba 61 fields · synced Jul 25, 2026
- EUDAMED 2a870da4-e322-40fc-98fb-9e93888bc4dc 61 fields · synced May 19, 2026