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Isolation gown (scrub suit, patient gown, CPE gown, PP gown, trousers, nursing pants，shorts)

by One Top Protective Products Co., Ltd.

Ref Scrub Suit 1708- SModel Scrub Suit 1708-S, 1708-M, 1708-L, 1708-XL, 1708-XXL Patient gown 1707-S, 1707-M, 1707-L, 1707-XL, 1707-XXL CPE gown 6714-S, 6714-M, 6714-L, 6714-XL, 6714-XXL Isolation gown 5503-S, etc

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 Number697867649IG01UC Basic UDI-DI 06978676490002UDI-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  • Withdrawn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
Isolation gown (scrub suit, patient gown, CPE gown,PP gown,trousers, nursing pants，shorts)
Model / Reference
Scrub Suit 1708-S, 1708-M, 1708-L, 1708-XL, 1708-XXL Patient gown 1707-S, 1707-M, 1707-L, 1707-XL, 1707-XXL CPE gown 6714-S, 6714-M, 6714-L, 6714-XL, 6714-XXL Isolation gown 5503-S, etc, Scrub Suit 1708- S
Primary DI / UDI-DI
06978676490002
Basic UDI-DI
697867649IG01UC
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