Simpass

by Simeks Tibbi Urunler San. ve Tic LTD STI 721 variants

Ref SE12060-80Model Simpass Endo35 OTW

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

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number86993436PTA35OTWHL Basic UDI-DI 08699343617659UDI-DI	Date17 Feb 2026Registered	StatusActive

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Simpass Endo35 OTW PTA Balloon Dilatation Catheter
Model / Reference: Simpass Endo35 OTW, SE12060-80

Primary DI / UDI-DI: 08699343617659
Basic UDI-DI: 86993436PTA35OTWHL
EMDN Code: C010402020101 PTA balloon dilatation catheters

Device Class: Class IIa
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