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D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

NL-MF-000015696 · Netherlands · Zuidland

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. is registered in the European database on medical devices as a manufacturer, with 586 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa558
Class IIb28

Among these devices, 447 are declared sterile, 6 implantable, 110 reusable, 47 active.

Devices declared under this manufacturer

Showing 12 of 586 declared devices.

Catalogue references include 1273.ES, 1286.C305, 1286.CD06, 3269.SBS04, 8525.4060000000009, 9311.23K01.

European nomenclature codes declared: Z1212020785, Q020499, Z12129085, Q02040301, L1799, L170201.

United States market access

FDA establishment registerRegistered with FDA
Matched entryD.O.R.C. Dutch Ophthalmic Research Center (International) B.V. (NL) · FDA 9611516
Devices in EUDAMED586
Country of registrationNetherlands

Device-level evidence

Devices with a numeric GTIN586
Found in the U.S. device database381
Share65.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryD.O.R.C DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V.

What it holds in Canada

Licences on record14
Currently active0
Class 2 devices12
Class 3 devices2
First licensed1999-06-11

Licence types: Device Family (6), System (3), Device Group Family (2), Single Device (2).

Licensed under: EVA NEXUS- SURGICAL PACKS AND KITS, SUB RETINAL CANNULA, VITRECTOMY LENS SYSTEM, FIBER OPTIC CABLE, ENDOILLUMINATION PROBE, MICROFORCEPS.

North American profile: Both markets. D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. is registered in both the United States and Canada.

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