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Temren

by İnvamed Sağlik İlaç Sanayi̇ Ve Ti̇caret A.Ş. 3 variants

Ref ATA0002, ATA0005, ATA0004

Active European Union

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-8683498158464GJ Basic UDI-DI Date16 Nov 2023RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Temren Atherectomy System II 5F, 135 cm
Temren Atherectomy System V 7F, 135 cm
Temren Atherectomy System IV 7F, 90cm
Model / Reference
ATA0002, ATA0005, ATA0004
Primary DI / UDI-DI
D-8683498158464GJ, D-8683498158488GY, D-8683498158471GF
Basic UDI-DI
B-8683498158464GJ, B-8683498158488GY, B-8683498158471GF
EMDN Code
C010402020602 Peripheral atherectomy systems, rotational
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000019963

Other devices from İnvamed Sağlik İlaç Sanayi̇ Ve Ti̇caret A.Ş.

See all devices from İnvamed Sağlik İlaç Sanayi̇ Ve Ti̇caret A.Ş. →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No