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Silicone Manual Resuscitator

by Xiamen Compower Medical Tech. Co., Ltd. 48 variants

Ref EMR0103005Model LSIA-001/RTMA1,LSIA-001/RTMA2,LSIA-001/RTMA3,LSIA-002/RTMA2,LSIA-002/RTMA3,LSIA-003/RTMA2,LSIA-003/RTMA3,Infant,Pediatric,Adult

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 Number694643041759104R6 Basic UDI-DI Date15 Mar 2024RegisteredStatusActive

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  • Withdrawn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
LSIA-001/RTMA1, LSIA-001/RTMA2, LSIA-001/RTMA3, LSIA-002/RTMA2, LSIA-002/RTMA3, LSIA-003/RTMA2, LSIA-003/RTMA3, Infant, Pediatric, Adult, EMR0103005
Primary DI / UDI-DI
06946430422699, 06946430422552, 06946430422835, 06946430419880, 06946430425812
Basic UDI-DI
694643041759104R6
Direct Marketing DI
06946430422699
06946430422552
06946430422835
06946430419880
06946430425812
EMDN Code
R03020201 Manually operated pulmonary resuscitators
Device Class
Class IIa
EU market of registration
Germany
Romania
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000011703
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Pulmonary resuscitator, manual, single-use

Other devices from Xiamen Compower Medical Tech. Co., Ltd.

See all devices from Xiamen Compower 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