EU → US Device Access

Johnson & Johnson International

BE-MF-000008018 · Belgium · Diegem

Johnson & Johnson International is registered in the European database on medical devices as a manufacturer, with 83 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I82
Class IIa1

Most frequent device types declared: MERSILENE, Silk Suture, EH6623H, EDP46, ZV805H.

Among these devices, 82 are declared sterile, 82 implantable, 1 reusable.

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 EUDAMED83
Country of registrationBelgium
⚠️ 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
MDR 730051supplemented2028-05-29
MDR 730030supplemented2027-12-19

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