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Universal Sequencing Reaction Kit G400 HM FCL SE50
EUDAMEDClass A (EU MDR)
Ref 1000028239
Identity
- Trade Name
- Universal Sequencing Reaction Kit G400 HM FCL SE50 EUDAMED
- Device Name
- Universal Sequencing Reaction Kit EUDAMED
- Model / Reference
- 1000028239 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974318130657 EUDAMED
- Basic UDI-DI
- 697431813S-KitMW EUDAMED
- Direct Marketing DI
- 06974318130657 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 G400 HM FCL SE50 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 f91c9fb6-f099-417a-a9ab-a97a2b0d1c1c 61 fields · synced Jul 16, 2026