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Starter

by Lake Region Medical Inc. 67 variants

Part of a family of 84 devices: see the family page

Ref SCMBF-170V

Starter (SCMBF-170V) is a Class III device made by Lake Region Medical, registered in EUDAMED on 5 May 2025 (Basic UDI-DI 081634901PTFEVASN2) with CE/MDR certificate TD745.179 valid until 15 Dec 2030, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

15 Dec 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier National Standards Authority of Ireland (NSAI)

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberTD745.179 Date16 Dec 2025IssuedStatusActive expires 15 Dec 2030

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TD745.179 Active

    Technical documentation EU MDR

    Certifier
    National Standards Authority of Ireland (NSAI) 0050
    Issued
    16 Dec 2025
    Expires
    15 Dec 2030

Timeline

3 dated events

  1. Registered EUDAMED 081634901PTFEVASN2
  2. Certificate issued EUDAMED TD745.179
  3. Certificate expires EUDAMED TD745.179

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
PTFE Guidewires (Vascular)
Model / reference
SCMBF-170V
Primary DI / UDI-DI
00816349013263
Basic UDI-DI
081634901PTFEVASN2
EMDN code
C04020102 Peripheral vascular diagnostic guidewires, non-hydrophilic
Device class
Class III
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000033013
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC.

Other devices from Lake Region Medical

  • Starter

    Class III

  • HiWire

    Class IIa

  • PV Tracker

    Class III

  • AddWire

    Class I

See all devices from Lake Region Medical →

Properties

  • Supplied sterile
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
Other properties (12, all answered No)