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Ankle Supports

by Dongguan Supercare Medical Products Co., Ltd EUDAMED

Active European Union

Ref AK-001, AK-033 M, SAB2, AK-021 S, AK-027 XL, AK-009 M, AK-041 M, AK-020 M, AK-042 M, AK-033 XL, AK-017 S, AK-004 S, AK-001 L, AK-024 S, HJ-005 M, AK-025 XL, SAB6, AK-027 M, AK-014 M, AK-022 U, AK-009 L, AK-018 S, AK-029 L/XL, AK-059 M, AK-031 L, AK-010 M, AK-054 L, FI-006 L, AK-023 U, AK-035 XL, SAB1, SAB4, AK-040 S, AK-041 L, AK-035 M, BM-006 S, AK-042 S, AK-031 M, AK-015 L, AK-009 S, AK-003 M, AK-007 L, AK-035 S, AK-018 M, AK-036 XL, AK-002 S, AK-004 M, AK-012 U, AK-014 S, AK-038 S, AK-028 XLModel AK-001,AK-002,AK-003,AK-004,AK-008,AK-012,AK-016,AK-017,AK-018,AK-021,AK-022,AK-023,AK-025,AK-027,AK-032,AK-033,AK-034,AK-038,AK-040,AK-051,AK-052,AK-054, etc, AK-001 AK-002 AK-003 AK-004 AK-016 AK-017 AK-018 AK-027 AK-033 AK-034 AK-038 AK-040 AK-062etc

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697278239AnkleSupports8J Basic UDI-DIDate20 Apr 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Ankle Supports
Model / Reference
AK-001, AK-002, AK-003, AK-004, AK-008, AK-012, AK-016, AK-017, AK-018, AK-021, AK-022, AK-023, AK-025, AK-027, AK-032, AK-033, AK-034, AK-038, AK-040, AK-051, AK-052, AK-054, etc, AK-001 AK-002 AK-003 AK-004 AK-016 AK-017 AK-018 AK-027 AK-033 AK-034 AK-038 AK-040 AK-062etc, AK-033 M, SAB2, AK-021 S, AK-027 XL, AK-009 M, AK-041 M, AK-020 M, AK-042 M, AK-033 XL, AK-017 S, AK-004 S, AK-001 L, AK-024 S, HJ-005 M, AK-025 XL, SAB6, AK-027 M, AK-014 M, AK-022 U, AK-009 L, AK-018 S, AK-029 L/XL, AK-059 M, AK-031 L, AK-010 M, AK-054 L, FI-006 L, AK-023 U, AK-035 XL, SAB1, SAB4, AK-040 S, AK-041 L, AK-035 M, BM-006 S, AK-042 S, AK-031 M, AK-015 L, AK-009 S, AK-003 M, AK-007 L, AK-035 S, AK-018 M, AK-036 XL, AK-002 S, AK-004 M, AK-012 U, AK-014 S, AK-038 S, AK-028 XL
Primary DI / UDI-DI
06972782392335, 06978927536114, 06972782392625, 06972782392427, 06978927536107, 06978927538545, 06978927538903, 06978927538743, 06978927538941, 06978927536138, 06972782392403, 06972782392366, 06978927535834, 06978927538774, 06978927536350, 06978927536077, 06972782392663, 06978927536084, 06978927538668, 06972782392434, 06978927538552, 06972782392410, 06978927536534, 06978927536626, 06978927536565, 06978927538583, 06978927536244, 06978927536336, 06972782392441, 06978927536602, 06972782392618, 06972782392649, 06972782392519, 06978927538910, 06978927536589, 06972782392571, 06978927538934, 06978927536558, 06978927536459, 06978927538538, 06978927535889, 06978927538514, 06978927536572, 06978927536008, 06978927538880, 06972782392342, 06978927535919, 06972782392380, 06978927538651, 06972782392502, 06978927536510
Basic UDI-DI
697278239AnkleSupports8J, 697892753AnkleSupportsGZ
EMDN Code
Y090699 Devices for body protection - other
Device Class
Class I
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

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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