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85830

EUDAMED

Class IIa (EU MDR)

Ref 85830Model ENDOKIT

by Advance Medical Integration Systems

Identity

Trade Name: 85830 EUDAMED
Device Name: 85830 EUDAMED
Model / Reference: ENDOKIT EUDAMED
85830 EUDAMED

Identifiers

Primary DI / UDI-DI: 03760392530208 EUDAMED
Basic UDI-DI: B-03760392530208 EUDAMED
EMDN Code: G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Gastro-urological guidewire, single-use

85830 by Advance Medical Integration Systems — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Gastro-urological guidewire, single-use.

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Optimos™ Guidewire — Taewoong Medical · Class II

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer: Advance Medical Integration Systems
EUDAMED SRN: FR-MF-000014717

Sources (1)

EUDAMED 815a8cf6-82bf-4533-815a-3f632b9457f5 61 fields · synced Aug 2, 2026