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Universal Cyclization Reaction Kit SD-SB

EUDAMED

Class A (EU MDR)

Ref 940-000141-00Model SD-SB, SD-DB, SD-App-A, App-A

by Wuhan MGI Tech Co., Ltd.

Identity

Trade Name
Universal Cyclization Reaction Kit SD-SB EUDAMED
Device Name
Universal Cyclization Reaction Kit EUDAMED
Model / Reference
SD-SB, SD-DB, SD-App-A, App-A EUDAMED
940-000141-00 EUDAMED

Identifiers

Primary DI / UDI-DI
06974318130589 EUDAMED
Basic UDI-DI
697431813C-KitGE EUDAMED
Direct Marketing DI
06974318130589 EUDAMED
EMDN Code
W010699 GENETIC TESTS - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Latvia 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 Cyclization Reaction Kit SD-SB by Wuhan MGI Tech 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

EUDAMED SRN
CN-MF-000018732
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED f8efe948-f04d-4033-8504-7245f580431d 61 fields · synced Jul 31, 2026