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Neo NON STERILE GAUZE SWABS

by Jianerkang Medical Co., Ltd.

Ref 05.28651428

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69218655NJEKGS019M Basic UDI-DI 06921865504103UDI-DIDate29 Nov 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Gauze Swab (Sponge)
Model / Reference
05.28651428
Primary DI / UDI-DI
06921865504103
Basic UDI-DI
69218655NJEKGS019M
Direct Marketing DI
06921865504103
EMDN Code
M0201020102 Cotton gauzes, folded, without x-ray detectable thread, non-sterile
Device Class
Class I
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000011206
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jianerkang Medical Co., Ltd.

See all devices from Jianerkang Medical Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • 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