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Sterile Gauze Swabs

by Medwell Medical Products Co., Ltd. China EUDAMED

Ref 286547Model B002, B001

EMDN M0201020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697055784B002EQ Basic UDI-DIDate5 Jun 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Trade Name
Sterile Gauze Swabs
Fcare STERILE GAUZE SWABS
Device Name
Sterile Gauze Swab without X-Ray
Model / Reference
B002, 286547, B001
Primary DI / UDI-DI
06970557844119
Basic UDI-DI
697055784B002EQ, 697055784B001EN
EMDN Code
M0201020101 Cotton gauzes, folded, without x-ray detectable thread, sterile
Device Class
Class I
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000020397
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Medwell Medical Products Co., Ltd.

See all devices from Medwell Medical Products Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 5c1a33fb-837a-44c2-b382-0fc5954c4b54 61 fields · synced 25 Oct 2026
  • EUDAMED 06970557844119|697055784B001EN 61 fields · synced 25 Oct 2026