UroDapter®

by TIK d.o.o., proizvodnja medicinskih pripomočkov

Ref 64717

Active European Union

CE MDR

Valid until

14 Sep 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

Certifier SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

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	NumberMDR-0051	Date15 Sep 2026Issued	StatusActive expires 14 Sep 2031
European Union	CE/MDR	Number38389554240009M Basic UDI-DI 13838955647179UDI-DI	Date1 Sep 2026Registered	StatusActive

Certificates

1 certificate · EUDAMED

MDR-0051 Active

Quality management system EU MDR

Certifier

SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ 1304

Issued
15 Sep 2026

Expires
14 Sep 2031

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Urological syringe adapter
Model / Reference: 64717

Primary DI / UDI-DI: 13838955647179
Basic UDI-DI: 38389554240009M
EMDN Code: U1302 Kits for bladder washing and instillation

Device Class: Class I
EU market of registration: Hungary

Manufacturer details

EUDAMED SRN: SI-MF-000037990

Other devices from TIK d.o.o., proizvodnja medicinskih pripomočkov

Ialuadapter®

Class I

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