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Orbisana Healthcare GmbH

Manufacturer of medical devices registered in the European database in Troisdorf, Germany.

Registration number (SRN)DE-MF-000023387
RoleManufacturer
StatusInactive
CountryGermany
City53831 Troisdorf
AddressBiberweg, 24 - 26 53831 Troisdorf
Registered on2022-04-27

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryOrbisana Healthcare GmbH (DE) · FDA 9614936

Notified body certificates

CertificateStatusExpiryTypeBody
HZ 1396541-1cancelled2029-09-24Quality management systemNB 0197

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

This operator is listed as inactive. The register does not publish the reason — cessation, change of legal form, or withdrawal from the European market. We do not guess it.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

This operator is no longer active. Are you buying from it?

An inactive registration is not, by itself, a verdict — it may be a cessation, a change of legal form, or a withdrawal from the Union market, and the register does not say which. What we can tell you is when a supplier's status changes: the register does not date those changes, so only comparing two snapshots reveals them. That is what the monitoring does.

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