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Malaria Whole Blood Combo Test
EUDAMEDClass IVD General (EU MDR)
Ref R13-110Ref R13-116
Identity
- Device Name
- Malaria Whole Blood Combo Test EUDAMED
- Model / Reference
- R13-110 EUDAMEDR13-116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571813009 EUDAMED06941571813016 EUDAMED
- Basic UDI-DI
- B-06941571813009 EUDAMEDB-06941571813016 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 Combo 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-06941571813009 | 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 40e88a22-ba22-4aeb-b513-d393559de57a 61 fields · synced Oct 6, 2026
- EUDAMED a28dddad-360e-4c6b-8686-ff2513aba151 61 fields · synced May 18, 2026