Dr Sapporo Hanna Affelt Sp. j.
PL-MF-000044757 · Poland · Toruń
Dr Sapporo Hanna Affelt Sp. j. is registered in the European database on medical devices as a manufacturer, with 57 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 57 |
|---|
Most frequent device types declared: 6 warstw, 80x200, L, M, S.
Devices declared under this manufacturer
- Aparat korekcyjny na haluksy Bunito Duo
- Krążek przeciwodleżynowy Puck
- Poduszka ortopedyczna CPAP
- Poduszka ortopedyczna Jazz
- Poduszka ortopedyczna London
- Poduszka ortopedyczna Nuvo
- Poduszka ortopedyczna Open
- Poduszka ortopedyczna Rock
- Poduszka ortopedyczna Salsa
- Przeciwodleżynowa mata do łóżka Vento
- Przeciwodleżynowe siedzisko na wózek inwalidzki Ergo-Vent
- Przeciwodleżynowe siedzisko na wózek inwalidzki Ergo-Vent Plus
Showing 12 of 57 declared devices.
Catalogue references include 5908249910447, 5908249910485, 5908249910508, 5908249910553, 5908249910751, 5908249910768.
European nomenclature codes declared: Y180999, Y0999, Y122406, V080302, V080702, Z12069099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 57 |
| Country of registration | Poland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 57 |
|---|---|
| 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. Dr Sapporo Hanna Affelt Sp. j. was not found in either the U.S. or the Canadian register.