Identity
- Trade Name
- MONO Rapid Test EUDAMED
- Device Name
- MONO Rapid Test EUDAMED
- Model / Reference
- IMO-N402B-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983115803 EUDAMED
- Basic UDI-DI
- 6970277510000KXX EUDAMED
- EMDN Code
- W0105099003 MONONUCLEOSIS (EBV) - 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
MONO 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 Unknown
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6970277510000KXX | Class C | Unknown |
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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 (1)
- EUDAMED 5a963b1e-cb80-48b2-81af-e1aa0c5ce2b6 61 fields · synced Jun 20, 2026