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Medical Polymeric Splint

by Hebei Sanxin Pharmaceutical Technology Co., Ltd. 23 variants

Ref 353x920x3.2Model 120x195x2.4 145x230x2.4 155x250x2.4 170x270x2.4 220x250x2.4 190x290x2.4 155x310x2.4 175x320x2.4 190x340x2.4 195x360x2.4 238x480x2.4 175x500x2.4 218x590x2.4 295x610x3.2 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697890768MPS3L Basic UDI-DI 06978907680165UDI-DIDate31 Aug 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  • Withdrawn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

Model / Reference
120x195x2.4 145x230x2.4 155x250x2.4 170x270x2.4 220x250x2.4 190x290x2.4 155x310x2.4 175x320x2.4 190x340x2.4 195x360x2.4 238x480x2.4 175x500x2.4 218x590x2.4 295x610x3.2 etc., 353x920x3.2
Primary DI / UDI-DI
06978907680165
Basic UDI-DI
697890768MPS3L
EMDN Code
M03050202 Synthetic cast bandages and splints
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057708
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hebei Sanxin Pharmaceutical Technology Co., Ltd.

See all devices from Hebei Sanxin Pharmaceutical Technology 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