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Universal Sequencing Reaction Kit T7 App-D FCL PE100
EUDAMEDClass A (EU MDR)
Ref 940-001494-00Ref 940-001400-00
Identity
- Trade Name
- Universal Sequencing Reaction Kit T7 App-D FCL PE100 EUDAMEDUniversal Sequencing Reaction Kit (Package III) T7 App-D FCL PE100 EUDAMED
- Device Name
- Universal Sequencing Reaction Kit EUDAMED
- Model / Reference
- 940-001494-00 EUDAMED940-001400-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974318131821 EUDAMED
- Basic UDI-DI
- 697431813S-KitMW EUDAMED
- Direct Marketing DI
- 06974318131821 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 T7 App-D FCL 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 (2)
- EUDAMED e1bc1bb1-1cbf-4949-826d-87cdfd8ffc18 61 fields · synced Jul 19, 2026
- EUDAMED 9f6cf64d-1be0-46d8-8a34-31b1e5687476 61 fields · synced Jul 19, 2026