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Disposable Non-woven Molton Glove

by Sunrise Tech Enterprises Corp

Ref 06978296970045Model SH-WS0225

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697829697SH01WC Basic UDI-DI 06978296970045UDI-DIDate17 Mar 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  • Withdrawn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
Disposable Non-woven Molton Glove
Model / Reference
SH-WS0225, 06978296970045
Primary DI / UDI-DI
06978296970045
Basic UDI-DI
697829697SH01WC
EMDN Code
T0199 Gloves - other
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000046869
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Related devices

Category: Radiation shielding apron

Other devices from Sunrise Tech Enterprises Corp

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