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Nano coulomb breath analyzer

by Sunvou Medical Electronics Co., Ltd. EUDAMED

Active European Union

Ref Sunvou-TM2120

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971022540147 Basic UDI-DIDate24 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Nano coulomb breath analyzer
Model / Reference
Sunvou-TM2120
Primary DI / UDI-DI
06971022540147
Basic UDI-DI
B-06971022540147
EMDN Code
W02020199 Cell counting instruments - other
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000004543
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Sunvou Medical Electronics Co., Ltd.

See all devices from Sunvou Medical Electronics Co., Ltd. →

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No