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Sleeve Cover (PP sleeve cover, SMS sleeve cover, Microporous sleeve cover, PE sleeve cover, PVC sleeve cover)

by One Top Protective Products Co., Ltd.

Ref PP Sleeve cover 1301- L/XLModel PP Sleeve cover 1301- L/XL SMS Sleeve cover 1302- L/XL Microporous Sleeve cover 1303- L/XL PE Sleeve cover 2301- L/XL PVC Sleeve cover 7301- L/XL

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 Number697867649SC02VY Basic UDI-DI 06978676491306UDI-DIDate12 Jun 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  • Withdrawn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
Sleeve Cover (PP sleeve cover, SMS sleeve cover, Microporous sleeve cover, PE sleeve cover, PVC sleeve cover)
Model / Reference
PP Sleeve cover 1301- L/XL SMS Sleeve cover 1302- L/XL Microporous Sleeve cover 1303- L/XL PE Sleeve cover 2301- L/XL PVC Sleeve cover 7301- L/XL, PP Sleeve cover 1301- L/XL
Primary DI / UDI-DI
06978676491306
Basic UDI-DI
697867649SC02VY
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000023063
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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