i-Stitch Rinsing Needle Luer-Lock Connector

by A.M.I. Agency for Medical Innovations GmbH

Ref IST1060

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number++EAMIA3B1C1D1H6 Basic UDI-DI +EAMIIST10600UDI-DI	Date27 Aug 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: i-Stitch Cleaning Instruments
Model / Reference: IST1060

Primary DI / UDI-DI: +EAMIIST10600
Basic UDI-DI: ++EAMIA3B1C1D1H6
Direct Marketing DI: +EAMIIST10600
EMDN Code: Z12011301 Cleaning and disinfection equipment

Device Class: Class I
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: AT-MF-000016792

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Properties

Other properties (13)

Sterile: No
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