Identity
- Trade Name
- MONO Rapid Test EUDAMED
- Device Name
- MONO Rapid Test EUDAMED
- Model / Reference
- IMO-N402J-25 EUDAMEDIMO-402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983116176 EUDAMED06970277513289 EUDAMED
- Basic UDI-DI
- 6970277510000KXX EUDAMEDB-06970277513289 EUDAMED
- EMDN Code
- W0105099003 MONONUCLEOSIS (EBV) - RT & POC EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General 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
MONO Rapid Test by Hangzhou Alltest Biotech.Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6970277510000KXX | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 6970277510000KXX | Class C | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED f612165a-7df9-4624-9281-54248200601b 61 fields · synced Jul 9, 2026
- EUDAMED addc241b-d639-47dc-9697-f9c29abd28e1 61 fields · synced Jul 9, 2026