MACHEREY-NAGEL GmbH & Co. KG
DE-MF-000005636 · Germany · Düren
MACHEREY-NAGEL GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 88 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: Medi-Test Glucose, Medi-Test URYXXON® Stick 10, NucleoMag® Dx Pathogen, NucleoSpin® Dx RNA Blood, NucleoSpin® Dx Virus.
Devices declared under this manufacturer
- BlemaStrip® 5.6 - 8.0 (120)
- BlemaStrip® pH 5.4 - 7.4
- BlemaStrip® pH 5.6 - 8.0 (27)
- Medi-Test Combi 10® SGL
- Medi-Test Combi 2
- Medi-Test Combi 5N®
- Medi-Test Combi 7L
- Medi-Test Glucose
- Medi-Test Glucose / Keton
- Medi-Test Protein 2
- Medi-Test URYXXON® Stick 10
- NucleoSpin® Dx Virus
Showing 12 of 88 declared devices.
Catalogue references include 740895.50, 902950.1, 93001.005, 93027, 93035, 93067.004.
European nomenclature codes declared: W0101060201, W0101060299, W020101020101, W0580, W0105900101, W01010699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MACHEREY-NAGEL GMBH & CO., KG. (DE) · FDA 4580 |
| Devices in EUDAMED | 88 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 88 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. MACHEREY-NAGEL GmbH & Co. KG is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IX 1038121-4 | issued | 2028-05-15 |
IX 1038121-3 | issued | 2028-05-15 |
IX 1038121-2 | issued | 2028-05-15 |
IX 1038121-1 | issued | 2028-05-15 |
HX 1038121-1 | issued | 2028-05-15 |