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Knee Sleeve

by Welsheng Corp. EUDAMED 16 variants

Active European Union

Ref 647R1-BK-S-1, 647R1-BK-L-1, 647R1-BK-XL-1, 647R1-WT-S-1, 647R1-WT-M-1, HMK200-BK-XL-1, 647R1-DB-XL-1, 647R1-DB-M-1, 639-TAN-XL-CC-1, 647R1-BL-M-1, 647R1-BL-S-1, 647R1-GY-S-1, 647R1-YW-S-1, 647R1-GY-M-1, 647R1-GY-L-1, 647R1-BK-M-1, 647R1-BL-XL-1, 647R1-WT-XL-1, 639-TAN-M-CC-1

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471988489CL102GJ Basic UDI-DIDate4 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Trade Name
Knee Sleeve
Knee Sleeve with Criss-Cross Elastic
Device Name
Lower Extremity Orthoses
Model / Reference
647R1-BK-S-1, 647R1-BK-L-1, 647R1-BK-XL-1, 647R1-WT-S-1, 647R1-WT-M-1, HMK200-BK-XL-1, 647R1-DB-XL-1, 647R1-DB-M-1, 639-TAN-XL-CC-1, 647R1-BL-M-1, 647R1-BL-S-1, 647R1-GY-S-1, 647R1-YW-S-1, 647R1-GY-M-1, 647R1-GY-L-1, 647R1-BK-M-1, 647R1-BL-XL-1, 647R1-WT-XL-1, 639-TAN-M-CC-1
Primary DI / UDI-DI
04719890077745, 04719890077769, 04719890077776, 04719890077820, 04719890077837, 04719884897823, 04719890077936, 04719890077912, 04719890079558, 04719890077790, 04719890077783, 04719890077943, 04719890077981, 04719890077950, 04719890077967, 04719890077752, 04719890077813, 04719890077851, 04719890079534
Basic UDI-DI
471988489CL102GJ
EMDN Code
Y061299 Lower extremity orthoses - other
Device Class
Class I
Market of Registration
Malta

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

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