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Adult Diapers

by Sunkiss Healthcare (Zhejiang) Co., Ltd. 8 variants

Ref L-15Model S/M(PINK),L/XL(PINK),S/M(WHITE),L/XL(WHITE),S/M(BLUE),L/XL(BLUE),S/M(GREY),L/XL(GREY) S,M,L-15,XL,XXL S-12,M-12,L-12,XL-12

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697115584AD0028F Basic UDI-DI 06971155842408UDI-DIDate20 May 2026RegisteredStatusActive

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  • Withdrawn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
Adult Diapers
Model / Reference
S/M(PINK), L/XL(PINK), S/M(WHITE), L/XL(WHITE), S/M(BLUE), L/XL(BLUE), S/M(GREY), L/XL(GREY) S, M, L-15, XL, XXL S-12, M-12, L-12, XL-12
Primary DI / UDI-DI
06971155842408
Basic UDI-DI
697115584AD0028F
EMDN Code
T04010103 Incontinence nappies with integrated fixing system
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000034778
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Sunkiss Healthcare (Zhejiang) Co., Ltd.

See all devices from Sunkiss Healthcare (Zhejiang) 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