Ureteral Access Sheath

by Chengdu Daxan Innovative Medical Tech.Co., Ltd China EUDAMED

Ref H04-Y1035Model Y type EMDN U03010202

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697197678DXACE0302VQ Basic UDI-DI	Date16 Mar 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference: Y type, H04-Y1035

Primary DI / UDI-DI: 06942214108162
Basic UDI-DI: 697197678DXACE0302VQ
EMDN Code: U03010202 Ureteral dilators

Device Class: Class IIa
Market of Registration: France

Manufacturer details

EUDAMED SRN: CN-MF-000033805
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Chengdu Daxan Innovative Medical Tech.Co., Ltd

J Type Ureteral Stent

Class IIa
Disposable Intermittent Catheter

Class I
Ureteral Access Sheath

Class IIa
Disposable Intermittent Catheter

Class I
J Type Ureteral Stent

Class IIa
J Type Ureteral Stent

Class IIa

See all devices from Chengdu Daxan Innovative Medical Tech.Co., Ltd →

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 72ede1a2-404d-4eef-b45c-75cd87cc6c5a 61 fields · synced 24 Oct 2026