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Genetic Sequencer HELICON® G50
EUDAMEDClass A (EU MDR)
Ref 900-000743-00Model DNBSEQ-G50, DNBSEQ-G400, DNBSEQ-T7, DNBSEQ-G99, DNBSEQ-G99A, HELICON® G400, HELICON® G50
Identity
- Trade Name
- Genetic Sequencer HELICON® G50 EUDAMED
- Device Name
- Genetic Sequencer EUDAMED
- Model / Reference
- DNBSEQ-G50, DNBSEQ-G400, DNBSEQ-T7, DNBSEQ-G99, DNBSEQ-G99A, HELICON® G400, HELICON® G50 EUDAMED900-000743-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974318131913 EUDAMED
- Basic UDI-DI
- 697431813SEQSY EUDAMED
- Direct Marketing DI
- 06974318131913 EUDAMED
- EMDN Code
- W02050108 GENETIC SYSTEM READERS 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
Genetic Sequencer HELICON® G50 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 | 697431813SEQSY | 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 fc3ae767-6cfc-4376-9716-20f694adce6e 61 fields · synced Jul 9, 2026