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Medis Medical Imaging Systems bv

NL-MF-000002670 · Netherlands · Leiden

Medis Medical Imaging Systems bv is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa8

Most frequent device types declared: 2022, 2024, 20240115, 2025, Medis QFR XA.

Among these devices, 6 are declared active, 8 with a measuring function.

Devices declared under this manufacturer

Catalogue references include 20220504, 20240115, 20250203, 9.51.450.2025, MEDISQFRXA, Medis QFR XA 2022.

European nomenclature codes declared: Z12050582, Z11030592.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryMEDIS MEDICAL IMAGING SYSTEMS, B.V. (NL) · FDA 9614587
Devices in EUDAMED8
Country of registrationNetherlands

⚠️ A similar name exists; we do not assert it is the same company — why.

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryMEDIS MEDICAL IMAGING SYSTEMS B.V.

⚠️ A similar name exists; unverified — why.

Notified body certificates

CertificateStatusExpiry
MDR 00044-Aissued2029-06-27

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