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Universal Sequencing Reaction Kit (Package IV) T7 App-D FCL SE100
EUDAMEDClass A (EU MDR)
Ref 940-001393-00
Identity
- Trade Name
- Universal Sequencing Reaction Kit (Package IV) T7 App-D FCL SE100 EUDAMED
- Device Name
- Universal Sequencing Reaction Kit EUDAMED
- Model / Reference
- 940-001393-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974318131784 EUDAMED
- Basic UDI-DI
- 697431813S-KitMW EUDAMED
- Direct Marketing DI
- 06974318131784 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 (Package IV) T7 App-D FCL SE100 by Wuhan MGI Tech Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 cf5ef8c4-44c0-4fce-b00c-e907d1d3cbe8 61 fields · synced Jul 9, 2026