I-Stop

by APIS Technologies Switzerland EUDAMED

Ref IS-HELICO-01, IS-1, IS-11-RO, IS-RPU, IS-TOT

EMDN U070101

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-03760151650192 Basic UDI-DI	Date8 Apr 2026Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: IS-HELICO-01, IS-1, IS-11-RO, IS-RPU, IS-TOT

Primary DI / UDI-DI: 03760151650192, 03760151650017, 03760151650109, 03760151650710, 03760151650680
Basic UDI-DI: B-03760151650192, B-03760151650017, B-03760151650109, B-03760151650710, B-03760151650680
EMDN Code: U070101 Sling systems for the treatment of incontinence

Device Class: Class IIb
Class III
Market of Registration: France

Manufacturer details

EUDAMED SRN: CH-MF-000039694
Authorised representative: DiLo Medical FR-AR-000000159

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Properties & raw data

Show properties, registry sources and raw records

Sterile
Implantable

Other properties (9)

Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No

Sources (5)

EUDAMED f230c2b9-42d6-4c5f-baf7-6645d9e6d0e4 61 fields · synced 22 Oct 2026
EUDAMED 6c68c972-99cd-4b6b-b340-e929b03c6821 61 fields · synced 17 May 2026
EUDAMED 099a7861-0523-4e58-9589-94c85e9dc56a 61 fields · synced 18 May 2026
EUDAMED 6110fe76-36bc-40dd-a577-fa8687d3d9df 61 fields · synced 18 May 2026
EUDAMED 6e34a937-345c-42f6-a983-82ac725987ec 61 fields · synced 18 May 2026