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Shun Monitor®

EUDAMED

Class III (EU MDR)

Ref 609151

by Shunmei Medical Co., Ltd

Identity

Trade Name
Shun Monitor® EUDAMED
Device Name
Central Venous Catheter Kit EUDAMED
Model / Reference
609151 EUDAMED

Identifiers

Primary DI / UDI-DI
06956014491515 EUDAMED
Basic UDI-DI
B-06956014491515 EUDAMED
EMDN Code
C01020201 CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED EUDAMED

Classification

Device Class
Class III EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Central venous catheterization kit, short-term

Shun Monitor® by Shunmei Medical Co., Ltd — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Central venous catheterization kit, short-term.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
CN-MF-000001160
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (1)

  • EUDAMED 52b7246b-3bc4-4b56-94b8-e9c8bc90b02c 61 fields · synced Jul 9, 2026