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Tek-Bal Tibbi̇ Ci̇hazlar San. Ve Ti̇c. Ltd. Şti̇. (

by Tek-Bal Tibbi̇ Ci̇hazlar San. Ve Ti̇c. Ltd. Şti̇. 6 variants

Ref STR-500

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-08680659070450 Basic UDI-DI 08680659070450UDI-DIDate23 Jun 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
500 Litre Yatay Buharlı Sterilizatör (500 Liter Horizontal Steam Sterilizer)
Model / Reference
STR-500
Primary DI / UDI-DI
08680659070450
Basic UDI-DI
B-08680659070450
EMDN Code
S9099 Sterilisation devices (excluding cat. d - z) - other
Device Class
Class IIa
Special Device Type
-1192
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000021319

Other devices from Tek-Bal Tibbi̇ Ci̇hazlar San. Ve Ti̇c. Ltd. Şti̇.

See all devices from Tek-Bal Tibbi̇ Ci̇hazlar San. Ve Ti̇c. Ltd. Şti̇. →

Properties

Other properties (11)

  • Sterile: No
  • 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