bitop medical GmbH
DE-MF-000047028 · Germany · Dortmund
bitop medical GmbH is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 10 |
|---|---|
| Class IIb | 7 |
Most frequent device types declared: ANS02/ANS03/ANS07, EHT01 / EHT04, EIC01, ERS03/ERS04, SNS01.
Devices declared under this manufacturer
- Diclodent® Spray Oral
- Granions® Spray Nasal Sinusite
- RINONEBIAL
- medEctoin® Allergy Nasal Spray 2%
- medEctoin® Allergy Nasal Spray Forte
- medEctoin® Mouth and Throat Spray Mint
- medEctoin® Mouth and Throat Spray Salvia
- medEctoin® Rhinitis Nasal Spray
- medEctoin® Soft Lozenges Wildberry
- medEctoin® Vaginal Gel
- medEctoin®Allergy Nasal Spray 1%
Showing 12 of 17 declared devices.
Catalogue references include 34300/ERS03, 34301/ERS04, 38020/ANS02, 38021, 38023, 38027.
European nomenclature codes declared: Q0399, U0899.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| 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 | 17 |
|---|---|
| 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 medical GmbH was not found in either the U.S. or the Canadian register.