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Manual Resuscitators

by Multigate Co., Ltd 3 variants

Ref AN128031NSModel AN128031NS、AN128032NS、AN128033NS

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697201396MU2ANNNNSMR001LC Basic UDI-DI 06972013964645UDI-DIDate27 Aug 2025RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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

Model / Reference
AN128031NS、AN128032NS、AN128033NS, AN128031NS
Primary DI / UDI-DI
06972013964645
Basic UDI-DI
697201396MU2ANNNNSMR001LC
EMDN Code
R03020201 Manually operated pulmonary resuscitators
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000002513
Authorised representative
RFX+Care International A/S DK-AR-000001768

Related devices

Category: Pulmonary resuscitator, manual, single-use

Other devices from Multigate 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