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Upper Limbs Supports

by Dongguan Supercare Medical Products Co., Ltd 119 variants

Ref SD-004 L-LEFTModel SD-001 SD-003 SD-004 SD-013 SD-014 FI-002 BM-003 EB-020 SD-007 EB-007FG-002 FG-006A FG-006B 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697892753UpperLimbBrace2R Basic UDI-DI 06978927535001UDI-DIDate15 May 2026RegisteredStatusActive

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  • Withdrawn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
Upper Limbs Supports
Model / Reference
SD-001 SD-003 SD-004 SD-013 SD-014 FI-002 BM-003 EB-020 SD-007 EB-007FG-002 FG-006A FG-006B etc, SD-004 L-LEFT
Primary DI / UDI-DI
06978927535001
Basic UDI-DI
697892753UpperLimbBrace2R
EMDN Code
Y060621 Shoulder orthoses
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000028597
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Dongguan Supercare Medical Products Co., Ltd

See all devices from Dongguan Supercare Medical Products 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