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Mediware

by Sterilance Medical (Suzhou) Inc. 14 variants

Ref "steel B2 01"

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6945630150BN Basic UDI-DI 16945630135276UDI-DIDate17 Feb 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Disposable Steel Lancets
Model / Reference
"steel B2 01"
Primary DI / UDI-DI
16945630135276
Basic UDI-DI
6945630150BN
Unit of Use DI
06945630135279
EMDN Code
A019013 Percutaneous needles
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000002860
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Sterilance Medical (Suzhou) Inc.

See all devices from Sterilance Medical (Suzhou) Inc. →

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