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Full-face Masks

by Shenyang RMS Medical Tech Co., Ltd. 3 variants

Ref FM-1MModel FM-1S, FM-1M, FM-1L

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 linked in EUDAMED

A group certificate may exist

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 Number6957469403002DZ Basic UDI-DI 06957469401838UDI-DIDate28 Jun 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Full-face Masks
Model / Reference
FM-1S, FM-1M, FM-1L
Primary DI / UDI-DI
06957469401838
Basic UDI-DI
6957469403002DZ
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000023286
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Shenyang RMS Medical Tech Co., Ltd.

See all devices from Shenyang RMS Medical Tech 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