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Tsk Bmb Surelock

by TSK Laboratory, Japan 6 variants

Ref BTS-13100, BMB-11100, BMB-08100, BMB-13100Model BTS-08100

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4571225300005UE Basic UDI-DI Date10 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Tsk Bmb Surelock
Tsk Bmb
Model / Reference
BTS-08100, BTS-13100, BMB-11100, BMB-08100, BMB-13100
Primary DI / UDI-DI
04580708058047, 04580708062648, 04580708062624, 04580708062679
Basic UDI-DI
4571225300005UE
EMDN Code
A01020201 Iliac-sternal biopsy needles and kits
Device Class
Class IIa
EU 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

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Properties

  • 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