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Universal DNBSEQ OneStep DNB Make Reagent Kit OS-App
EUDAMEDClass A (EU MDR)
Ref 940-002480-00Model OS-App
Identity
- Trade Name
- Universal DNBSEQ OneStep DNB Make Reagent Kit OS-App EUDAMED
- Device Name
- Universal DNBSEQ OneStep DNB Make Reagent Kit EUDAMED
- Model / Reference
- OS-App EUDAMED940-002480-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974318132910 EUDAMED
- Basic UDI-DI
- 697431813OS-KitS2 EUDAMED
- Direct Marketing DI
- 06974318132910 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Latvia 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
Universal DNBSEQ OneStep DNB Make Reagent Kit OS-App by Wuhan MGI Tech Co., Ltd. — Class A — 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 | 697431813OS-KitS2 | Class A | Active |
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Manufacturer
- Manufacturer
- Wuhan MGI Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000018732
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED a46446fb-2774-416f-b0aa-6c9cbcdb3e12 61 fields · synced Jun 18, 2026