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Coverall (PP coverall, SMS coverall, Microporous coverall.PP+PE coverall)

by One Top Protective Products Co., Ltd.

Ref A601- SModel A601-S-5XL A602-S-5XL A603-S-5XL A604-S-5XL A605-S-5XL A606-S-5XL A607-S-5XL

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 Number697867649C01W2 Basic UDI-DI 06978676491733UDI-DIDate11 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  • Withdrawn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
Coverall (PP coverall, SMS coverall, Microporous coverall.PP+PE coverall)
Model / Reference
A601-S-5XL A602-S-5XL A603-S-5XL A604-S-5XL A605-S-5XL A606-S-5XL A607-S-5XL, A601- S
Primary DI / UDI-DI
06978676491733
Basic UDI-DI
697867649C01W2
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

Other devices from One Top Protective Products Co., Ltd.

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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