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Automated Sequencing Library Preparation System MGIFLP-L
EUDAMEDClass A (EU MDR)
Ref 900-000636-00, 900-000875-00Model MGIFLP-L, GenSIRO-16
Identity
- Trade Name
- Automated Sequencing Library Preparation System MGIFLP-L EUDAMED
- Device Name
- Automated Sequencing Library Preparation System EUDAMED
- Model / Reference
- MGIFLP-L, GenSIRO-16 EUDAMED900-000636-00, 900-000875-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974318131234 EUDAMED
- Basic UDI-DI
- 697431813MGIFLPN2 EUDAMED
- Direct Marketing DI
- 06974318131234 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automated Sequencing Library Preparation System MGIFLP-L 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 | 697431813MGIFLPN2 | 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 ea31ef75-07b0-4dd0-8ddd-4d5bf2349059-1 61 fields · synced Jun 18, 2026
- EUDAMED ea31ef75-07b0-4dd0-8ddd-4d5bf2349059-2 61 fields · synced Jun 18, 2026