Astra Biotech GmbH
DE-MF-000026439 · Germany · Berlin
Astra Biotech GmbH is registered in the European database on medical devices as a manufacturer, with 67 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: Multi DNA Extraction Kit, Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form F), Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form S), Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T), Neisseria gonorrhoeae PCR kit.
Devices declared under this manufacturer
- Magnetic DNA / RNA Auto Extraction kit
- Multi DNA Extraction kit
- Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form F)
- Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form S)
- Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit (Form T)
- Prime DNA/RNA Extraction kit
Showing 12 of 67 declared devices.
Catalogue references include 20-01 A, 21-03, 21-04 A, 50-03 A, 80-09, 84-01.
European nomenclature codes declared: W010501080302, W010501080303, W0105900101, W01020201, W01020410, W0105010203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 67 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 67 |
|---|---|
| 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. Astra Biotech GmbH was not found in either the U.S. or the Canadian register.