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Nebulizer

by Shenzhen Combei Technology Co., Ltd. EUDAMED

Active European Union

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69481584NEB01SX Basic UDI-DIDate31 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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.

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, PN100(IN 525)
Primary DI / UDI-DI
06948158405220
Basic UDI-DI
69481584NEB01SX
Direct Marketing DI
06948158405220
EMDN Code
R060101 Cold nebulisation systems
Device Class
Class IIa
Market of Registration
Germany

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