Rolf Kullgren AB
SE-MF-000021108 · Sweden · Gnesta
Rolf Kullgren AB is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 24 |
|---|
Most frequent device types declared: 4-3000, Lactal Pessary, Lactal Vaginal Gel.
Devices declared under this manufacturer
- Balance Activ BV Treatment Gel
- Canesbalance
- Canesten GYNO Balance
- GineCanesbalance
- Gyno-Canesbalance
- Gynolind Balance Activ
- HydralinBalance
- INTIMOHELP
- Lactal Balans
- Lactal Vaginal Gel
- LactalBalance
- LactalBalans
Showing 12 of 24 declared devices.
Catalogue references include 200895, 30002, 30005, 30075, 31-6TF, 320865.
European nomenclature codes declared: U0803.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 24 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
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. Rolf Kullgren AB was not found in either the U.S. or the Canadian register.