← Back to catalogue

GeneMind

EUDAMED

Class IVD General (EU MDR)

Ref L000188Model 24 tests/kitRef L000196Model 96 tests/kitRef S000493Model FASTA FCM 150, FASTA FCM 300, FASTA FCM-D 75-D, FASTA FCH 150, FASTA FCH 300, FASTA FCH-D 75-DRef S000395Ref S000334Model 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 S000486Ref S000497Model S-1 FCL-D 100-D,S-1 FCL 100,S-1 FCL 300,S-1 FCM-D 100-D,S-1 FCM 100,S-1 FCM 300Ref M000004Model MrLH-96 DxRef L000197Ref S000339Ref S000400Model 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-DRef L000189Ref S000428Model FCH 50cycles,FCH 100cycles,FCH 200cycles,FCH 300cycles,FCH 50cycles,FCH 100cycles,FCH 200cycles,FCH 300cyclesRef S000331Ref S000333Ref S000408Ref L000200Ref SQ00065Model SURFSeq Q DxRef L000187Ref S000487Ref S000426Ref S000489Ref L000186Ref S000399Ref L000106Ref S000490Ref S000335Ref S000492Ref S000396Ref S000491Ref S000330Ref SQ00078Model FASTASeq S DxRef S000498Ref L000202Ref L000198Ref S000336

by GeneMind Biosciences Co., Ltd.

Identity

Trade Name
GeneMind EUDAMED
Device Name
Colon Cancer Multi-gene Mutation Combined Detection Kit ( Sequencing Method) EUDAMED
Preimplantation Genetic Testing for Monogenic Defects Kit (Sequencing Method) EUDAMED
Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing） EUDAMED
SURFSeq 5000 Dx Universial Reaction Kit for Sequencing EUDAMED
FASTASeq S Dx Universal Reaction Kit for Sequencing EUDAMED
Automated Sample Preparation System EUDAMED
Lung Cancer Multi-gene Mutation Combined Detection Kit ( Sequencing Method) EUDAMED
SURFSeq Q Dx Universal Reaction Kit for Sequencing EUDAMED
Solid Tumor Circulating Tumor DNA Multi-gene Combined Detection Kit ( Sequencing Method) EUDAMED
SURFSeq Q Dx Sequencing System EUDAMED
Colon Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit (Sequencing Method) EUDAMED
Cystic Fibrosis Detection Kit (Sequencing Method) EUDAMED
FASTASeq S Dx Sequencing System EUDAMED
Phenylketonuria Detection Kit Based On Clinical Exome Sequencing Technology (Sequencing Method) EUDAMED
Model / Reference
24 tests/kit EUDAMED
L000188 EUDAMED
96 tests/kit EUDAMED
L000196 EUDAMED
FASTA FCM 150, FASTA FCM 300, FASTA FCM-D 75-D, FASTA FCH 150, FASTA FCH 300, FASTA FCH-D 75-D EUDAMED
S000493 EUDAMED
S000395 EUDAMED
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
S000334 EUDAMED
S000486 EUDAMED
S-1 FCL-D 100-D,S-1 FCL 100,S-1 FCL 300,S-1 FCM-D 100-D,S-1 FCM 100,S-1 FCM 300 EUDAMED
S000497 EUDAMED
MrLH-96 Dx EUDAMED
M000004 EUDAMED
L000197 EUDAMED
S000339 EUDAMED
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
S000400 EUDAMED
L000189 EUDAMED
FCH 50cycles,FCH 100cycles,FCH 200cycles,FCH 300cycles,FCH 50cycles,FCH 100cycles,FCH 200cycles,FCH 300cycles EUDAMED
S000428 EUDAMED
S000331 EUDAMED
S000333 EUDAMED
S000408 EUDAMED
L000200 EUDAMED
SURFSeq Q Dx EUDAMED
SQ00065 EUDAMED
L000187 EUDAMED
S000487 EUDAMED
S000426 EUDAMED
S000489 EUDAMED
L000186 EUDAMED
S000399 EUDAMED
L000106 EUDAMED
S000490 EUDAMED
S000335 EUDAMED
S000492 EUDAMED
S000396 EUDAMED
S000491 EUDAMED
S000330 EUDAMED
FASTASeq S Dx EUDAMED
SQ00078 EUDAMED
S000498 EUDAMED
L000202 EUDAMED
L000198 EUDAMED
S000336 EUDAMED

Identifiers

Primary DI / UDI-DI
06974968584121 EUDAMED
06974968584183 EUDAMED
06974968583964 EUDAMED
06974968583605 EUDAMED
06974968583704 EUDAMED
06974968583919 EUDAMED
06974968583872 EUDAMED
06974968581045 EUDAMED
06974968584145 EUDAMED
06974968583759 EUDAMED
06974968583476 EUDAMED
06974968584138 EUDAMED
06974968583780 EUDAMED
06974968583674 EUDAMED
06974968583698 EUDAMED
06974968584008 EUDAMED
06974968584176 EUDAMED
06974968581083 EUDAMED
06974968584114 EUDAMED
06974968583940 EUDAMED
06974968583766 EUDAMED
06974968583926 EUDAMED
06974968584107 EUDAMED
06974968583636 EUDAMED
06974968583568 EUDAMED
06974968583957 EUDAMED
06974968583711 EUDAMED
06974968583933 EUDAMED
06974968583599 EUDAMED
06974968583988 EUDAMED
06974968583667 EUDAMED
06974968581090 EUDAMED
06974968583889 EUDAMED
06974968584206 EUDAMED
06974968584152 EUDAMED
06974968583728 EUDAMED
Basic UDI-DI
B-06974968584121 EUDAMED
B-06974968584183 EUDAMED
697496858FASTASeq-Kit2W EUDAMED
697496858BR01SURF50005C EUDAMED
697496858BZ01UU EUDAMED
697496858MrLH68 EUDAMED
B-06974968584145 EUDAMED
697496858R-Kit2U EUDAMED
B-06974968584138 EUDAMED
697496858BU01U3 EUDAMED
B-06974968584176 EUDAMED
697496858AG01SURFSeqQDx6M EUDAMED
B-06974968584114 EUDAMED
B-06974968584107 EUDAMED
B-06974968583568 EUDAMED
697496858AH01FASTASeqSYL EUDAMED
B-06974968584206 EUDAMED
B-06974968584152 EUDAMED
Direct Marketing DI
06974968583964 EUDAMED
06974968583605 EUDAMED
06974968583704 EUDAMED
06974968583919 EUDAMED
06974968583872 EUDAMED
06974968583759 EUDAMED
06974968583476 EUDAMED
06974968583780 EUDAMED
06974968583674 EUDAMED
06974968584008 EUDAMED
06974968583940 EUDAMED
06974968583766 EUDAMED
06974968583926 EUDAMED
06974968583636 EUDAMED
06974968583957 EUDAMED
06974968583711 EUDAMED
06974968583933 EUDAMED
06974968583599 EUDAMED
06974968583988 EUDAMED
06974968583667 EUDAMED
06974968583889 EUDAMED
06974968583728 EUDAMED
EMDN Code
W010699 GENETIC TESTS - OTHER EUDAMED
W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
W02050108 GENETIC SYSTEM READERS EUDAMED
W0106010101 CYSTIC FIBROSIS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class A EUDAMED
Market of Registration
Türkiye EUDAMED
Sweden EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMEDEUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMEDEUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMEDEUDAMED

New Device

No

EUDAMED

GeneMind by GeneMind Biosciences Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
GeneMind Biosciences Co., Ltd.
EUDAMED SRN
CN-MF-000025785
Authorised Representative
Medunion S.L. ES-AR-000019366

Sources (36)

  • EUDAMED 5b225e05-392e-4640-8fb7-875fdef6b5ff 61 fields · synced Aug 2, 2026
  • EUDAMED 678ff0f7-2f73-4fed-ac77-aece5de355bf 61 fields · synced May 11, 2026
  • EUDAMED 9c6fc31e-2928-4946-9f68-a32c8323d5b8 61 fields · synced May 11, 2026
  • EUDAMED 95cbf17d-679c-4ece-ae50-b225501cf87e 61 fields · synced May 16, 2026
  • EUDAMED c4a4ac3d-0166-433b-b5b9-8c4c47daee40 61 fields · synced May 16, 2026
  • EUDAMED 279f1e0d-abbc-4352-b213-b2e5563daca9 61 fields · synced May 16, 2026
  • EUDAMED 9efe7860-d8a2-4b5c-aacd-9a7b15c4d495 61 fields · synced May 16, 2026
  • EUDAMED 7de9bcae-d126-4590-8b7a-5331c5c90084 61 fields · synced May 16, 2026
  • EUDAMED 1c4fda86-cba4-48f5-b031-419a032bf317 61 fields · synced May 17, 2026
  • EUDAMED 49bef7d1-f328-495e-b154-c4c2b3aa9ba0 61 fields · synced May 17, 2026
  • EUDAMED db8f32ad-27e8-4c93-9e9d-6824752273a3 61 fields · synced May 17, 2026
  • EUDAMED a45f1230-c9c6-4532-a6a9-486f4acc40c1 61 fields · synced May 17, 2026
  • EUDAMED 098f1145-038d-4ffb-9f8e-47a916ea8ee2 61 fields · synced May 17, 2026
  • EUDAMED c3389e0a-22a7-4842-bd28-0a8d3b6f6bc0 61 fields · synced May 17, 2026
  • EUDAMED 7e2ab018-0357-4a16-8602-aedb29ff57b9 61 fields · synced May 17, 2026
  • EUDAMED 2821bdcd-793a-41c9-bfb1-ef5d90458f3d 61 fields · synced May 17, 2026
  • EUDAMED defc9598-f120-4ebd-b811-48f9918855f6 61 fields · synced May 17, 2026
  • EUDAMED ac987153-c2c4-435d-9631-2567a3b08250 61 fields · synced May 17, 2026
  • EUDAMED 521feb00-311f-4c11-8787-ebb696664096 61 fields · synced May 17, 2026
  • EUDAMED 8f5c5512-71f5-43a8-8e48-5b4fc8872e14 61 fields · synced May 17, 2026
  • EUDAMED 5b84f66b-9cde-4763-86d1-bf6fd042fd99 61 fields · synced May 18, 2026
  • EUDAMED e14854f6-117d-4a88-8085-755241b5d10c 61 fields · synced May 18, 2026
  • EUDAMED a693b2ac-6f72-4eab-8647-20e37eb501a1 61 fields · synced May 18, 2026
  • EUDAMED 57e0ad17-a6e4-4eb8-bc9a-d3334b158f05 61 fields · synced May 18, 2026
  • EUDAMED 7dd5d81c-f6ce-4967-acfe-00e247ee6d8c 61 fields · synced May 18, 2026
  • EUDAMED e288e47e-0998-4ed8-9a88-beab5706941d 61 fields · synced May 18, 2026
  • EUDAMED 59f5a39a-2598-4ca1-83c2-3ad5bdd32363 61 fields · synced May 18, 2026
  • EUDAMED 103cda58-88f8-4c49-bc57-2b9f450f946e 61 fields · synced May 18, 2026
  • EUDAMED 8cbfd7a7-6d7a-4d29-b46d-14b6534ea5a8 61 fields · synced May 18, 2026
  • EUDAMED 3ba5b5d7-9fa9-4f6d-a3e4-76af1ce9210c 61 fields · synced May 18, 2026
  • EUDAMED 9d6b49c5-a9a5-47d8-b780-70b75ab3079d 61 fields · synced May 18, 2026
  • EUDAMED 0fead89e-801a-490e-9b3f-ae95c4f746a1 61 fields · synced May 19, 2026
  • EUDAMED 036702e7-cf10-4002-ad22-30fc68df5dfd 61 fields · synced May 19, 2026
  • EUDAMED ab3ffc87-9122-43f0-83c7-e4df88342742 61 fields · synced May 19, 2026
  • EUDAMED 008b58b8-5cc3-437f-a7c7-3a0303acbf3e 61 fields · synced May 19, 2026
  • EUDAMED 41f8887b-2ab7-49a2-a029-22eb8871010c 61 fields · synced May 19, 2026