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Transcutaneous Jaundice Detector

by Ningbo David Medical Device Co., Ltd. China EUDAMED

Ref BM-100BModel BM-100A/BM-100B/BM-100C

EMDN Z12080410

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06920716301175 Basic UDI-DIDate26 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
BM-100B, BM-100A/BM-100B/BM-100C
Primary DI / UDI-DI
06920716301175, 06920716304220
Basic UDI-DI
B-06920716301175, 69207163BM-0016Q
Direct Marketing DI
06920716304220
EMDN Code
Z12080410 Transcutaneous bilirubinometers
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009962
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Ningbo David Medical Device Co., Ltd.

See all devices from Ningbo David Medical Device Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED dd172cdd-00a6-46cf-83ff-4d4de2f14724 61 fields · synced 22 Oct 2026
  • EUDAMED 06920716304220|69207163BM-0016Q 61 fields · synced 17 May 2026