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Oversleeve

by Hygiea Medical Technology (Beijing) Co., Ltd. 2 variants

Ref HMOSPE01, HMOSPE02, HMOSPE03, HMOSNW01, HMOSNW02, HMOSNW03Model HMOSPE01

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 Number697633971Oversleeve6R Basic UDI-DI 16976339710501UDI-DIDate5 Apr 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  • Withdrawn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

Model / Reference
HMOSPE01, HMOSPE02, HMOSPE03, HMOSNW01, HMOSNW02, HMOSNW03
Primary DI / UDI-DI
16976339710501
Basic UDI-DI
697633971Oversleeve6R
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000041007
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hygiea Medical Technology (Beijing) Co., Ltd.

See all devices from Hygiea Medical Technology (Beijing) 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