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Sinuscopes

by Tonglu Sike Medical Instrument Co., Ltd. China EUDAMED

Ref BJ1015Model BJ1001,BJ1002,BJ1003,BJ1004,BJ1008,BJ1009,BJ1010,BJ1011,BJ1012,BJ1013,BJ1014,BJ1015,BJ1016HD,BJ1017HD,BJ1018HD,BJ1019HD,BJ1032HD,BJ1033HD,BJ1034HD,BJ1035HD,BJ1040HD,BJ1041HD,BJ1042HD,BJ1043HD

EMDN Z12021008

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697058187BJ001DP Basic UDI-DIDate16 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sinuscopes
Model / Reference
BJ1001,BJ1002,BJ1003,BJ1004,BJ1008,BJ1009,BJ1010,BJ1011,BJ1012,BJ1013,BJ1014,BJ1015,BJ1016HD,BJ1017HD,BJ1018HD,BJ1019HD,BJ1032HD,BJ1033HD,BJ1034HD,BJ1035HD,BJ1040HD,BJ1041HD,BJ1042HD,BJ1043HD, BJ1015
Primary DI / UDI-DI
06975633110379
Basic UDI-DI
697058187BJ001DP
EMDN Code
Z12021008 Rhinoscopes
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000051027
Authorised representative
endodoctor GmbH DE-AR-000050606

Other devices from Tonglu Sike Medical Instrument Co., Ltd.

See all devices from Tonglu Sike Medical Instrument Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 329aee94-b6c8-405e-96f5-88bc32213b61 61 fields · synced 24 Oct 2026