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SURFSeq 5000 Dx Universial Reaction Kit for Sequencing

EUDAMED

Class A (EU MDR)

Ref S000227Model FCM 100/200/300 cycles,FCH 50/100/200/300 cycles,SURF FCM 100/200/300 cycles,SURF FCH 50/100/200/300 cycles,SURF FCP 50/100/200/300 cyclesRef S000226Ref S000224

by GeneMind Biosciences Co., Ltd.

Identity

Device Name
SURFSeq 5000 Dx Universial Reaction Kit for Sequencing EUDAMED
Model / Reference
FCM 100/200/300 cycles,FCH 50/100/200/300 cycles,SURF FCM 100/200/300 cycles,SURF FCH 50/100/200/300 cycles,SURF FCP 50/100/200/300 cycles EUDAMED
S000227 EUDAMED
S000226 EUDAMED
S000224 EUDAMED

Identifiers

Primary DI / UDI-DI
06974968583452 EUDAMED
06974968583445 EUDAMED
06974968583421 EUDAMED
Basic UDI-DI
697496858BR01SURF50005C 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

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

SURFSeq 5000 Dx Universial Reaction Kit for Sequencing 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

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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 (3)

  • EUDAMED 661828cf-4b2e-4fd3-bd9a-33d536aa2661 61 fields · synced Jul 12, 2026
  • EUDAMED 2d9cf631-fd4e-458b-92fb-26b910369361 61 fields · synced May 18, 2026
  • EUDAMED a7a4dd9a-e7c8-4c3e-92bc-bc945934764f 61 fields · synced May 18, 2026