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Back Support

by Tonglu Hunter Outdoor Products Inc 11 variants

Ref N\AModel TTS-030 TTS-029 TTS-034 8666 8665 0109 8016 8016B YC 8015 8330 YC 7813 YC 7814 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697675378HTBS01YZ Basic UDI-DI 06976753783085UDI-DIDate7 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  • Withdrawn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
Back Support
Model / Reference
TTS-030 TTS-029 TTS-034 8666 8665 0109 8016 8016B YC 8015 8330 YC 7813 YC 7814 etc, N\A
Primary DI / UDI-DI
06976753783085
Basic UDI-DI
697675378HTBS01YZ
EMDN Code
Y090699 Devices for body protection - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000037690
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Tonglu Hunter Outdoor Products Inc

See all devices from Tonglu Hunter Outdoor Products Inc →

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