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Corneal Topographer SK-7000A

EUDAMED

Class I (EU MDR)

Ref 164Model SK-7000A、SK-7000B

by ChongQing SunKingdom Medical Instrument Co., Ltd.

Identity

Trade Name
Corneal Topographer SK-7000A EUDAMED
Device Name
Corneal Topographer EUDAMED
Model / Reference
SK-7000A、SK-7000B EUDAMED
164 EUDAMED

Identifiers

Primary DI / UDI-DI
06973211071647 EUDAMED
Basic UDI-DI
69732110711CT7W EUDAMED
EMDN Code
Z12120123 COMPUTERISED CORNEAL TOPOGRAPHS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Corneal Topographer SK-7000A by Chongqing Sunkingdom Medical Instrument Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000014351
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (1)

  • EUDAMED a2b488d8-f10c-4c7b-a285-8949380a3ba1 61 fields · synced Oct 6, 2026