EU → US Device Access

HOIST MEDICAL

FR-MF-000026140 · France · Marseille

HOIST MEDICAL is registered in the European database on medical devices as a manufacturer, with 85 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa68
Class IIb17

Most frequent device types declared: PURFIT GASTROSTOMY BUTTON 14FR 3CM PGB14-3.0, STOMAFIT STOMA STOPER ST08-30, STARFIT NASOGASTRIC FEEDING TUBE, PURFIT GASTROSTOMY EXTENSION 60 CM PGE-60, STARFIT NASOGASTRIC FEEDING TUBE WITH GUIDEWIRE.

Among these devices, 61 are declared sterile.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED85
Country of registrationFrance
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
1000217799issued2029-10-31

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