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Heel spur insoles

by Since Household Care Co., LTD 19 variants

Ref TH09Model SH002/SM163/SH024/ SH021/SW001/SH004/SW002/SM010/SH021/H49/H48/H02/TH09/TH08/TH74/ TH01/TM21/TM46/SM120/SM021/SM059

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 Number697579554HSI01UE Basic UDI-DI 06975795543459UDI-DIDate8 Nov 2023RegisteredStatusActive

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  • Withdrawn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
Heel spur insoles
Model / Reference
SH002/SM163/SH024/ SH021/SW001/SH004/SW002/SM010/SH021/H49/H48/H02/TH09/TH08/TH74/ TH01/TM21/TM46/SM120/SM021/SM059, TH09
Primary DI / UDI-DI
06975795543459
Basic UDI-DI
697579554HSI01UE
EMDN Code
V0811 Heel, elbow and knee anti-decubitus protection aids
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000027717
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Since Household Care Co., LTD

See all devices from Since Household Care 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