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Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing）

EUDAMED

Class A (EU MDR)

Ref S000064Model FCM 150cycles,FCM 300cycles,FCH-D SE075-D,FCH 300cycles,FCH 150cycles,FCM-D SE075-D,GenoLab FCM 150cycles,GenoLab FCM 300cycles,GenoLab FCM-D SE075-D,GenoLab FCH 150cycles,GenoLab FCH 300cycles,GenoLab FCH-D SE075-D

by GeneMind Biosciences Co., Ltd.

Identity

Trade Name
Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing） EUDAMED
Device Name
Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing） EUDAMED
Model / Reference
FCM 150cycles,FCM 300cycles,FCH-D SE075-D,FCH 300cycles,FCH 150cycles,FCM-D SE075-D,GenoLab FCM 150cycles,GenoLab FCM 300cycles,GenoLab FCM-D SE075-D,GenoLab FCH 150cycles,GenoLab FCH 300cycles,GenoLab FCH-D SE075-D EUDAMED
S000064 EUDAMED

Identifiers

Primary DI / UDI-DI
06974968583049 EUDAMED
Basic UDI-DI
697496858R-Kit2U EUDAMED
EMDN Code
W010699 GENETIC TESTS - OTHER 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

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 Reaction Kit for Sequencing（Reversible Terminator Sequencing） by GeneMind Biosciences Co., Ltd. — Class A — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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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 (1)

  • EUDAMED 9b997a99-e062-40e3-a87f-43b07981c8a6 61 fields · synced Jun 17, 2026