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Orthopedic Splint

by Jiangsu Senolo Medical Technology Co., Ltd.

Ref XB212Model XB1,XB2,XB3,XB4,XB5,XB6,XB212,XB224,XB312,XB320,XB324,XB328,XB336,XB416,XB420,XB424,XB428,XB430,XB436,XB512,XB520,XB528,XB530,XB536,XB546,XB548,XB630,XB636,XB646,XB648,XB848

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69525344SPLINT007XZ Basic UDI-DI 06952534407012UDI-DIDate14 Jul 2025RegisteredStatusActive

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  • Withdrawn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
Orthopedic Splint
Model / Reference
XB1, XB2, XB3, XB4, XB5, XB6, XB212, XB224, XB312, XB320, XB324, XB328, XB336, XB416, XB420, XB424, XB428, XB430, XB436, XB512, XB520, XB528, XB530, XB536, XB546, XB548, XB630, XB636, XB646, XB648, XB848
Primary DI / UDI-DI
06952534407012
Basic UDI-DI
69525344SPLINT007XZ
EMDN Code
M03050201 Natural cast bandages and splints
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000008281
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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