← Back to catalogue
Malaria P.f. /P.v. Rapid Test
EUDAMEDClass C (EU MDR)
Ref IMPV-N402-25Ref IMPV-N402J-20Ref IMPV-N402J-25Ref IMPV-N402-20
Identity
- Trade Name
- Malaria P.f. /P.v. Rapid Test EUDAMED
- Device Name
- Malaria P.f. /P.v. Rapid Test EUDAMED
- Model / Reference
- IMPV-N402-25 EUDAMEDIMPV-N402J-20 EUDAMEDIMPV-N402J-25 EUDAMEDIMPV-N402-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983104722 EUDAMED06936983115964 EUDAMED06936983115971 EUDAMED06936983104715 EUDAMED
- Basic UDI-DI
- 6970277510000HXR EUDAMED
- EMDN Code
- W0105090401 PLASMODIUM (MALARIA) - RT & POC EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Ireland 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
New Device
No
EUDAMED
Malaria P.f. /P.v. Rapid Test by Hangzhou Alltest Biotech.Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6970277510000HXR | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (4)
- EUDAMED 3d4959a7-59aa-44dd-ab79-a92b02989bea 61 fields · synced Sep 18, 2026
- EUDAMED 287f57a1-d017-4f52-8afb-a50cffeb3c6e 61 fields · synced May 18, 2026
- EUDAMED 434a3214-e14d-4593-9983-d38ecb4dc82e 61 fields · synced May 18, 2026
- EUDAMED dc8bd835-e005-40e9-b7af-4b74be6ee25e 61 fields · synced May 18, 2026