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Dreisam

by Dreisam (Beijing) Medical Technology Co., Ltd. EUDAMED

Active European Union

Model D1/L1/S1/D1 Pro/L1 Pro/S1 Pro, L2, D2, L2 Pro, S2 Pro, S2, L3

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697605595G0DLS0HA Basic UDI-DIDate27 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Continuous Glucose Monitoring Device
Model / Reference
D1/L1/S1/D1 Pro/L1 Pro/S1 Pro, L2, D2, L2 Pro, S2 Pro, S2, L3
Primary DI / UDI-DI
06976055950055, 06976055950123, 06976055950116, 06976055950154, 06976055950161, 06976055950130, 06976055950185
Basic UDI-DI
697605595G0DLS0HA, 697605595G0L200BX, 697605595G0D200A7, 697605595G0L2P0EU, 697605595G0S2P0GD, 697605595G0S200DG, 697605595G0L300C4
EMDN Code
Z1204011502 Invasive blood sugar monitoring systems
Device Class
Class IIb
Market of Registration
Poland
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000047458
Authorised representative
Firsteck Bio Srl. IT-AR-000039427

Other devices from Dreisam (Beijing) Medical Technology Co., Ltd.

Properties

Show properties
  • Sterile
  • Measuring Function
Other properties (11)
  • 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