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COOLPRENE X Back Support with Extra Waist Support and Bilateral Compressive Straps

by Welsheng Corp. 2 variants

Ref 573CAR1-BK-L-1, 573CAR1-BK-M, 573CAR1-BK-XL, 573CAR1-BK-S-1, 727CAR1-BK-F-1, 573CAR1-BK-M-1, 771CN-BK-L-1, 771CN-BL-M-1, 771CN-TAN-S-1, 771CN-TAN-L-1, 771CN-TAN-M-1, 771CN-BL-L-1

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 Number471988489CL104GN Basic UDI-DI Date4 Sep 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  • Withdrawn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

Trade Name
COOLPRENE X Back Support with Extra Waist Support and Bilateral Compressive Straps
COOLPRENE X Back Support with Extra Waist Support
Coolprene Back Support
Device Name
Spine Orthoses
Model / Reference
573CAR1-BK-L-1, 573CAR1-BK-M, 573CAR1-BK-XL, 573CAR1-BK-S-1, 727CAR1-BK-F-1, 573CAR1-BK-M-1, 771CN-BK-L-1, 771CN-BL-M-1, 771CN-TAN-S-1, 771CN-TAN-L-1, 771CN-TAN-M-1, 771CN-BL-L-1
Primary DI / UDI-DI
04719890077721, 00840269504785, 00840269504808, 04719890077707, 04719890078742, 04719890077714, 04719890081803, 04719890081834, 04719890081865, 04719890081889, 04719890081872, 04719890081841
Basic UDI-DI
471988489CL104GN, 08402695CL1048J
EMDN Code
Y060399 Spine orthoses - other
Device Class
Class I
EU market of registration
Malta
Netherlands

Manufacturer details

EUDAMED SRN
TW-MF-000005197
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Welsheng Corp.

See all devices from Welsheng Corp. →

Properties

  • Contains Latex YesEUDAMEDNoEUDAMED

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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