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Sequencing System
EUDAMEDClass A (EU MDR)
Ref P000033Model GenoLab M DxRef SQ00021Model FASTASeq 300 Dx
Identity
- Device Name
- Sequencing System EUDAMED
- Model / Reference
- GenoLab M Dx EUDAMEDP000033 EUDAMEDFASTASeq 300 Dx EUDAMEDSQ00021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968581021 EUDAMED06974968581052 EUDAMED
- Basic UDI-DI
- 697496858LabMDx-CECF EUDAMED697496858FASTASeq300DxZL EUDAMED
- EMDN Code
- W02050108 GENETIC SYSTEM READERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
Sequencing System by GeneMind Biosciences 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 | 697496858LabMDx-CECF | Class A | Active |
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Manufacturer
- Manufacturer
- GeneMind Biosciences Co., Ltd.
- EUDAMED SRN
- CN-MF-000025785
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 7fc33604-9547-4655-be0a-c60e6c36f1b8 61 fields · synced Jul 14, 2026
- EUDAMED 5ee85bad-b5f4-45b4-b24c-dc933f4aea7e 61 fields · synced May 18, 2026