← Back to catalogue

Chromosomal Copy Number Variation Testing Kit （Single Molecule Direct Sequencin…

EUDAMED

Class IVD General (EU MDR)

Ref L000023Model 32 tests/kitRef L000022Model 16 tests/kit

by GeneMind Biosciences Co., Ltd.

Identity

Trade Name
Chromosomal Copy Number Variation Testing Kit （Single Molecule Direct Sequencing） EUDAMED
Device Name
Chromosomal Copy Number Variation Testing Kit （Single Molecule Direct Sequencing EUDAMED
Chromosomal Copy Number Variation Testing Kit （Single Molecule Direct Sequencing） EUDAMED
Model / Reference
32 tests/kit EUDAMED
L000023 EUDAMED
16 tests/kit EUDAMED
L000022 EUDAMED

Identifiers

Primary DI / UDI-DI
06974968583148 EUDAMED
06974968583131 EUDAMED
Basic UDI-DI
B-06974968583148 EUDAMED
B-06974968583131 EUDAMED
EMDN Code
W0106010399 CHROMOSOMAL DISORDERS TESTS - OTHER EUDAMED

Classification

Device Class
Class IVD General 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

Chromosomal Copy Number Variation Testing Kit （Single Molecule Direct Sequencin… by GeneMind Biosciences Co., Ltd. — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

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
Umedwings Netherlands B.V. NL-AR-000000444

Sources (2)

  • EUDAMED 4df52671-082a-49e3-b7d7-dc79c352e1ea 61 fields · synced Jul 29, 2026
  • EUDAMED e9aea266-bcd4-4a15-a944-4b2c440c17f9 61 fields · synced May 17, 2026