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Meditex

by Guangzhou Fuzelong Hygiene Material Co., Lt EUDAMED

Active European Union

Ref R1129 / MB-0302-G, R1130 / MB-0402-G, R1132/MC-0103, R1268 / S-0102, R3014 / MB-0405

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69218257SFM4N Basic UDI-DIDate11 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Surgical Masks
isolation gown
shoe cover
Model / Reference
R1129 / MB-0302-G, R1130 / MB-0402-G, R1132/MC-0103, R1268 / S-0102, R3014 / MB-0405
Primary DI / UDI-DI
06921825701559, 06921825701542, 06921825701580, 06921825701603, 06921825701566, 06921825703553
Basic UDI-DI
69218257SFM4N, 69218257T0205H5, 69218257T0208HB
EMDN Code
T020699, T0205, T0208
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000023141
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Guangzhou Fuzelong Hygiene Material Co., Lt

See all devices from Guangzhou Fuzelong Hygiene Material Co., Lt →

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