bitop AG
DE-MF-000006543 · Germany · Witten
bitop AG is registered in the European database on medical devices as a manufacturer, with 209 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 30 |
|---|---|
| Class IIa | 179 |
Most frequent device types declared: AAT02, AAT04, BAT04, EHK16, EHT01 / EHT04.
Among these devices, 70 are declared sterile.
Devices declared under this manufacturer
- Best View Antiallergische Augentropfen
- Conisan N® Augentropfen
- Ectoin® Dermatitis Cream 7%
- Ectoin® Sicca Eye Drops
- Granions® Mal de Gorge Intense Miel Citron Menthe
- Lysoin Red Fruits
- Mirfulan® Ectoin 5%
- Optase® Allergy Eye Drops
- Phytoxil Pastille Mal de Gorge miel citron menthe
- REVENTiL® rhinitis orrspray
- Rezitop®
- medEctoin® Allergy Relief Lozenges Cherry
Showing 12 of 209 declared devices.
Catalogue references include 30303, 30542, 30627, 30706, 33044, 38163.
European nomenclature codes declared: Q0399, Q02030299, V9099, R060203, U0899.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 209 |
| 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 | 37 |
|---|---|
| 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. bitop AG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 2678802-1 | reissued | 2029-02-26 |
HZ 1342003-1 | supplemented | 2029-02-26 |