EU → North America Device Access

SARSTEDT AG & Co.KG

DE-MF-000005649 · Germany · Nümbrecht

SARSTEDT AG & Co.KG is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Among these devices, 6 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 28 declared devices.

Catalogue references include 62.617.001, 65.716.041, 65.716.045, 65.716.048, 72.704.050, 72.704.056.

European nomenclature codes declared: W050301020202, A01010201, W050301020280, W050301020102, W05019001.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySARSTEDT AG & CO. KG (DE) · FDA 9617475
Devices in EUDAMED28
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN28
Found in the U.S. device database1
Share3.6 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entrySARSTEDT AG & CO. KG

What it holds in Canada

Licences on record4
Currently active0
Class 2 devices4
First licensed2002-04-09

Licence types: Device Family (4).

Licensed under: S-MONOVETTE NEEDLE, MULTIFLY NEEDLE WITH AND WITHOUT MULTI-ADAPTER, SAFETY NEEDLE, MICRO NEEDLE.

North American profile: Both markets. SARSTEDT AG & Co.KG is registered in both the United States and Canada.

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