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Infant Phototherapy Eye Mask

by Shandong Huasai Benquan Biotechnology Company Limited

Ref 0Model HS-I、 HS-II、 HS-III、 HS-IV、 HS-V

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 Number69570594YZ001YJ Basic UDI-DI 69570594001286UDI-DIDate29 Jul 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  • Withdrawn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
Infant Phototherapy Eye Mask
Model / Reference
HS-I、 HS-II、 HS-III、 HS-IV、 HS-V, 0
Primary DI / UDI-DI
69570594001286
Basic UDI-DI
69570594YZ001YJ
Direct Marketing DI
69570594001286
EMDN Code
V0201 Phototherapy masks
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000057549
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Shandong Huasai Benquan Biotechnology Company Limited

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