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Malaria Antigen Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref 303038501, 303036501
Identity
- Device Name
- Malaria Antigen Test Kit EUDAMED
- Model / Reference
- 303038501, 303036501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972412616237 EUDAMED
- Basic UDI-DI
- B-06972412616237 EUDAMED
- EMDN Code
- W0105090401 PLASMODIUM (MALARIA) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Malaria Antigen Test Kit by Hangzhou Laihe Biotech 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-06972412616237 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Laihe Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000033566
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ffdaf192-fb4d-4d79-b527-43675bb4c4cd 61 fields · synced Jun 19, 2026
- EUDAMED ffdaf192-fb4d-4d79-b527-43675bb4c4cd-1 61 fields · synced Jun 10, 2026