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Non sterile: Adult Diaper

by Samela, Inc. d/b/a NorthShore Care Supply 24 variants

Ref 2697Model MEGAMAX Tab-Style Diaper (SKU #’s 1268, 1271, 1274, 1277, 1280, 1283,1286, 1289, 1292, 1601, 1604, 1607,1610, 1613, 1616, 1619, 1622, 1625,1628, 1631 & 1634). etc

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 Number0193183AdultDiaper01MC Basic UDI-DI 00193183002111UDI-DIDate17 Mar 2025RegisteredStatusActive

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  • Withdrawn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
Non sterile: Adult Diaper
Model / Reference
MEGAMAX Tab-Style Diaper (SKU #’s 1268, 1271, 1274, 1277, 1280, 1283, 1286, 1289, 1292, 1601, 1604, 1607, 1610, 1613, 1616, 1619, 1622, 1625, 1628, 1631 & 1634). etc, 2697
Primary DI / UDI-DI
00193183002111
Basic UDI-DI
0193183AdultDiaper01MC
EMDN Code
Y0999 Personal care aids - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000046519
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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