Simpass

by Simeks Tibbi Urunler San. ve Tic LTD STI 241 variants

Ref STO15012Model Simpass CTO

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

Certifier UDEM Adriatic d.o.o.

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

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number86993436PTCACTOEA Basic UDI-DI 08699343611473UDI-DI	Date18 Nov 2025Registered	StatusActive
European Union	CE/MDR	NumberM.2025.MDR.1088-1	Date11 Nov 2025Issued	StatusWithdrawn expires 10 Nov 2028 withdrawn 18 May 2026

Certificates

1 certificate · EUDAMED

M.2025.MDR.1088-1 Withdrawn

Technical documentation EU MDR

Certifier

UDEM Adriatic d.o.o. 2696

Issued
11 Nov 2025

Expires
10 Nov 2028

Reason
Other

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Simpass CTO RX PTCA Balloon Dilatation Catheter
Model / Reference: Simpass CTO, STO15012

Primary DI / UDI-DI: 08699343611473
Basic UDI-DI: 86993436PTCACTOEA
EMDN Code: C010401020101 Ptca balloon dilation catheters

Device Class: Class III
EU market of registration: Türkiye

Manufacturer details

EUDAMED SRN: TR-MF-000015871

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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