Balloon Inflators

EUDAMED

Class I (EU MDR)

Ref FST-IF-40Ref FST-IF-60

by Foresight Technology Co., Ltd.

Identity

Trade Name: Balloon Inflators EUDAMED
Device Name: Balloon Inflators EUDAMED
Model / Reference: FST-IF-40 EUDAMED
FST-IF-60 EUDAMED

Identifiers

Primary DI / UDI-DI: 06957024905634 EUDAMED
06957024901445 EUDAMED
Basic UDI-DI: 695702496402KE EUDAMED
695702496401KC EUDAMED
Direct Marketing DI: 06957024905634 EUDAMED
06957024901445 EUDAMED
EMDN Code: G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: Austria EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Gastro-urological guidewire, single-use

Balloon Inflators by Foresight Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

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

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	695702496402KE	Class I	Active

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Manufacturer

Manufacturer: Foresight Technology Co., Ltd.
EUDAMED SRN: CN-MF-000009708
Authorised Representative: Creo Medical, S.L.U. ES-AR-000001355

Sources (2)

EUDAMED d5f76014-137d-400d-8a3b-0a27140b47ec 61 fields · synced Jul 16, 2026
EUDAMED 62f727d7-4e73-43f7-b67c-f57557a11905 61 fields · synced May 16, 2026