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Universal Sequencing Reaction Kit (Package V) T7 FCL PE100
EUDAMEDClass A (EU MDR)
Ref 940-001410-00
Identity
- Trade Name
- Universal Sequencing Reaction Kit (Package V) T7 FCL PE100 EUDAMED
- Device Name
- Universal Sequencing Reaction Kit EUDAMED
- Model / Reference
- 940-001410-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974318131593 EUDAMED
- Basic UDI-DI
- 697431813S-KitMW EUDAMED
- Direct Marketing DI
- 06974318131593 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 V) T7 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 (1)
- EUDAMED b910ebf5-a52c-441b-81b9-4824daf529b0 61 fields · synced Jul 17, 2026