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Universal Sequencing Reaction Kit G50 SM FCS PE100
EUDAMEDClass A (EU MDR)
Ref 1000022475
Identity
- Trade Name
- Universal Sequencing Reaction Kit G50 SM FCS PE100 EUDAMED
- Device Name
- Universal Sequencing Reaction Kit EUDAMED
- Model / Reference
- 1000022475 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974318130091 EUDAMED
- Basic UDI-DI
- 697431813S-KitMW EUDAMED
- Direct Marketing DI
- 06974318130091 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 Sequencing Reaction Kit G50 SM FCS PE100 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 | 697431813S-KitMW | 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 c1e0456c-f037-4767-995b-0dd5cfe618e7 61 fields · synced Jul 19, 2026