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Under Pad

by Insoftb(China)Co., Ltd

Ref 60*90cmModel 30*45CM/60*45CM/60*60CM/60*70CM/ 60*90CM/75*90CM/75*130CM/75*160CM/ 80*150CM/90*180CM/100*230CM

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69527538UPJC Basic UDI-DI 06952753800120UDI-DIDate7 Feb 2024RegisteredStatusActive

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  • Withdrawn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
Under Pad
Model / Reference
30*45CM/60*45CM/60*60CM/60*70CM/ 60*90CM/75*90CM/75*130CM/75*160CM/ 80*150CM/90*180CM/100*230CM, 60*90cm
Primary DI / UDI-DI
06952753800120
Basic UDI-DI
69527538UPJC
EMDN Code
T04010201, T04010202, T04010203, T04010299
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000008477
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Insoftb(China)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