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Claudicare

EUDAMED

Class IIb (EU MDR)

Ref SWCLD-EP-02

by Seawon Meditech Co., Ltd.

Identity

Trade Name
Claudicare EUDAMED
Device Name
Claudicare EUDAMED
Model / Reference
SWCLD-EP-02 EUDAMED

Identifiers

Primary DI / UDI-DI
08809272561552 EUDAMED
Basic UDI-DI
B-08809272561552 EUDAMED
EMDN Code
K01020101 MINIMALLY INVASIVE SURGERY DISSECTORS, SINGLE-USE EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Italy 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

Claudicare by Seawon Meditech Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
KR-MF-000007442
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (1)

  • EUDAMED 596ca840-2641-4150-a896-e77706d609d6 61 fields · synced Jun 19, 2026