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Nebulizer

by Shenzhen Combei Technology Co., Ltd. 3 variants

Ref PN100Model PN100,Prolife NA10,Pempa NEB500, IN 525,IN A50 AGU N8,Prolife PN Mesh PN600,Pro Mesh, AGU SN10,Prolife PN Smart

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 Number69481584NEB01SX Basic UDI-DI 06948158400782UDI-DIDate31 Oct 2024RegisteredStatusWithdrawn No longer placed 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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Model / Reference
PN100, Prolife NA10, Pempa NEB500, IN 525, IN A50 AGU N8, Prolife PN Mesh PN600, Pro Mesh, AGU SN10, Prolife PN Smart
Primary DI / UDI-DI
06948158400782
Basic UDI-DI
69481584NEB01SX
Direct Marketing DI
06948158400782
EMDN Code
R060101 Cold nebulisation systems
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000016047
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shenzhen Combei Technology Co., Ltd.

See all devices from Shenzhen Combei Technology Co., Ltd. →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No