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Claudicare

EUDAMED

Class IIb (EU MDR)

Ref SWCLD-EP-SN1Ref SWCLD-EP-SN2Ref SWCLD-EP-04Ref SWCLD-EP-SRef SWCLD-EP-LN2

by Seawon Meditech Co., Ltd.

Identity

Trade Name
Claudicare EUDAMED
Device Name
Claudicare EUDAMED
Model / Reference
SWCLD-EP-SN1 EUDAMED
SWCLD-EP-SN2 EUDAMED
SWCLD-EP-04 EUDAMED
SWCLD-EP-S EUDAMED
SWCLD-EP-LN2 EUDAMED

Identifiers

Primary DI / UDI-DI
08809272563396 EUDAMED
08809272563402 EUDAMED
08809272561576 EUDAMED
08809272562412 EUDAMED
08809272563426 EUDAMED
Basic UDI-DI
B-08809272563396 EUDAMED
B-08809272563402 EUDAMED
B-08809272561576 EUDAMED
B-08809272562412 EUDAMED
B-08809272563426 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 (5)

  • EUDAMED 53d2778a-2562-4cdf-8bf8-60934c77db49 61 fields · synced Aug 4, 2026
  • EUDAMED 0a9d4836-883c-45d6-bf1b-74e6de9a3443 61 fields · synced May 11, 2026
  • EUDAMED 8d169b29-4431-454c-88b2-27ddfb1fb329 61 fields · synced May 17, 2026
  • EUDAMED 336357cf-8a51-4a14-bc66-68d376def1be 61 fields · synced May 17, 2026
  • EUDAMED a088398f-71ba-4b22-9e34-53e988c7c3be 61 fields · synced May 19, 2026