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Disposable isolation gown

by Ningjin Runboda Medical Protective Products Co., Ltd. 4 variants

Ref LModel M,L,XL,XXL

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 Number698035687DIG001G3 Basic UDI-DIDate24 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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 isolation gown
Model / Reference
M, L, XL, XXL
Primary DI / UDI-DI
06980356870097
Basic UDI-DI
698035687DIG001G3
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017347
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Ningjin Runboda Medical 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