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Fcare Medicals ΜΠΛΟΥΖΕΣ ΑΣΘΕΝΩΝ ΡΡ 40g ΣΚΟΥΡΟ ΜΠΛΕ ΧΩΡΙΣ ΜΑΝΙΚΙΑ

by Feixi Hongwei Medical Devices Co., Ltd

Ref REF:2865140Model PP Isolation gown; SMS Isolation gown; SMMS Isolation gown; SMMMS Isolation gown; Nonwoven Gown; PE Laminated Isolation gown; Patient gown; Visitor Gown; Scrub Suit; Patient Suit; CPE Gown

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697491661ISOG0112T Basic UDI-DI 06974916612296UDI-DIDate6 May 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  • Withdrawn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
Disposable Isolation Gown
Model / Reference
PP Isolation gown, SMS Isolation gown, SMMS Isolation gown, SMMMS Isolation gown, Nonwoven Gown, PE Laminated Isolation gown, Patient gown, Visitor Gown, Scrub Suit, Patient Suit, CPE Gown, REF:2865140
Primary DI / UDI-DI
06974916612296
Basic UDI-DI
697491661ISOG0112T
EMDN Code
T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
Device Class
Class I
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000033411
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Feixi Hongwei Medical Devices Co., Ltd

See all devices from Feixi Hongwei Medical Devices 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