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Small steam sterilizers

by Ningbo Rundeer Control Equipment Co., Ltd. EUDAMED

Active European Union

Ref IFU-SEA-01Model SEA16, SEA8, SEA18, SEA12, SEA23

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06974913926020 Basic UDI-DIDate26 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Small steam sterilizers
Model / Reference
SEA16, IFU-SEA-01, SEA8, SEA18, SEA12, SEA23
Primary DI / UDI-DI
06974913926020, 06974913926006, 06974913926037, 06974913926013, 06974913926044
Basic UDI-DI
B-06974913926020, B-06974913926006, B-06974913926037, B-06974913926013, B-06974913926044
EMDN Code
Q010399 Surgical dental devices - other
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000040569
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Ningbo Rundeer Control Equipment Co., Ltd.

See all devices from Ningbo Rundeer Control Equipment Co., Ltd. →

Properties

Show properties
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No