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Tsk Bmb Surelock

by TSK Laboratory, Japan United States EUDAMED

Ref BTS-11100Model BTS-08100 EMDN A01020201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4571225300005UE Basic UDI-DIDate10 Mar 2026RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
BTS-08100, BTS-11100
Primary DI / UDI-DI
04580708058016
Basic UDI-DI
4571225300005UE
EMDN Code
A01020201 Iliac-sternal biopsy needles and kits
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
JP-MF-000008485
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Tsk Laboratory, Japan

See all devices from Tsk Laboratory, Japan →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 04580708058016|4571225300005UE 61 fields · synced 25 Oct 2026