Cystoflex™ Reverse Deflection

by Axess Vision Technology United States EUDAMED

Ref 11010012Model 11010011

EMDN Z12020701

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number3664977EMDNZ12020701P8 Basic UDI-DI	Date26 Mar 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Cystoflex™ Standard Deflection
Model / Reference: 11010011, 11010012

Primary DI / UDI-DI: 03664977000066
Basic UDI-DI: 3664977EMDNZ12020701P8
EMDN Code: Z12020701 Cystoscopes

Device Class: Class I
Market of Registration: France

Manufacturer details

EUDAMED SRN: FR-MF-000003039

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Class II
Broncoflex Vortex

Class IIa
10030001/20030001/30030000

Class I
Cystoflex™ Standard Deflection

Class I

Properties & raw data

Show properties, registry sources and raw records

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

Sources (1)

EUDAMED 659d3c74-1750-4b9c-899e-c082e75949c8 61 fields · synced 22 Oct 2026