Diagnotix B.V.
NL-MF-000000236 · Netherlands · Appingedam
Diagnotix B.V. is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: 1020 M VB1B6, 1100 M STP, 1220 M VC, 4030 P AEDX, 4090 P PS3.
Devices declared under this manufacturer
- Anti-Epileptic Drugs Expanded Panel Reagent Set
- Antibiotics Reagent Set
- Clozapine Reagent Set
- Immunosuppressants Reagent Set
- Metanephrines Reagent Set
- Methylmalonic Acid Reagent Set
- Mycophenolic Acid Reagent Set
- Psychotropic Medication 3 Reagent Set
- Steroid Basic Panel Reagent Set
- Tacrolimus Reagent Set
- Valproic Acid Reagent Set
- Vitamin A & E Reagent Set
Showing 12 of 29 declared devices.
Catalogue references include 1060 M MET, 1080 M VAE, 1220 M VC, 4090 P PS3, 4180 P IMM, 4200 P TAC.
European nomenclature codes declared: W0102152201, W0102090204, W0102060203, W0102080602,W0102080603,W0102080604,W0102080606, W0102080699, W0102070299,W0102152006.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 29 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| 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: Neither register. Diagnotix B.V. was not found in either the U.S. or the Canadian register.