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Rotavirus-Adenovirus-Astrovirus-Norovirus Combo Test
EUDAMEDClass B (EU MDR)
Ref A4B630Model Format (cassette): A4B63011 A4B630125 A4B630140 A4B63021 A4B630225 A4B630240
Identity
- Trade Name
- Rotavirus-Adenovirus-Astrovirus-Norovirus Combo Test EUDAMED
- Device Name
- Rotavirus-Adenovirus-Astrovirus-Norovirus Combo Test EUDAMED
- Model / Reference
- Format (cassette): A4B63011 A4B630125 A4B630140 A4B63021 A4B630225 A4B630240 EUDAMEDA4B630 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804832971 EUDAMED
- Basic UDI-DI
- 69528048A4B63006L EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Rotavirus-Adenovirus-Astrovirus-Norovirus Combo Test by Assure Tech. (hangzhou) Co., Ltd. — Class B — 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 | 69528048A4B63006L | Class B | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 398c2e02-49bb-442f-b7b8-e6fbfc8fb493 61 fields · synced Jun 18, 2026