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Offisoins - Nasal Irrigator

by Hui Zhou Suan Technology Co., Limited 5 variants

Ref SN-H04Model SN-H01, SN-H02, SN-H03, SN-H04, SN-H05, SN-H06, SN-H07, SN-H08, SN-H09, SN-H10, SN-H11, SN-H12

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 Number697620459NI01L9 Basic UDI-DI 06976204590330UDI-DIDate22 Jul 2024RegisteredStatusActive

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  • Withdrawn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
Nasal Irrigator
Model / Reference
SN-H01, SN-H02, SN-H03, SN-H04, SN-H05, SN-H06, SN-H07, SN-H08, SN-H09, SN-H10, SN-H11, SN-H12
Primary DI / UDI-DI
06976204590330
Basic UDI-DI
697620459NI01L9
EMDN Code
Q030199 Nasopharyngeal devices - other
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000043037
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hui Zhou Suan Technology Co., Limited

See all devices from Hui Zhou Suan Technology Co., 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