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Santecare Compresses Sterile Nonwoven

EUDAMED

Class I (EU MDR)

Ref 21013Model Synthetic Non-woven Swabs without X-ray Detectable ElementRef 180250Ref 21016

by Winner Medical Co., Ltd.

Identity

Trade Name
Santecare Compresses Sterile Nonwoven EUDAMED
Synthetic Non-woven Swabs without X-ray Detectable Element EUDAMED
Model / Reference
Synthetic Non-woven Swabs without X-ray Detectable Element EUDAMED
21013 EUDAMED
180250 EUDAMED
21016 EUDAMED

Identifiers

Primary DI / UDI-DI
16942327039916 EUDAMED
16942327048611 EUDAMED
16942327006031 EUDAMED
Basic UDI-DI
694109405483FE EUDAMED
Direct Marketing DI
16942327039916 EUDAMED
16942327006031 EUDAMED
EMDN Code
M0202010101 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France EUDAMED
Ireland EUDAMED

Clinical & Handling

Sterile

Yes

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

Santecare Compresses Sterile Nonwoven by Winner Medical 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

Manufacturer
Winner Medical Co., Ltd.
EUDAMED SRN
CN-MF-000005692
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (3)

  • EUDAMED b6f8d726-83db-4428-8d4d-70b079783f21 61 fields · synced Jul 14, 2026
  • EUDAMED 9ebdc54c-f491-42bd-a2fc-0664091dd0f8 61 fields · synced May 17, 2026
  • EUDAMED d13e3ed6-0e69-4ce0-a2a2-c06c3cbf5a52 61 fields · synced May 17, 2026