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Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Test
EUDAMEDClass IVD General (EU MDR)
Ref MI-F44001
Identity
- Trade Name
- Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Test EUDAMED
- Device Name
- Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Test EUDAMED
- Model / Reference
- MI-F44001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804827090 EUDAMED
- Basic UDI-DI
- B-06952804827090 EUDAMED
- EMDN Code
- W01050499 VIROLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Test by Assure Tech. (hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06952804827090 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 14114a35-2a37-46b3-a222-f4926d3a9e82 61 fields · synced Oct 6, 2026