Berkemann Hungary Bt.
HU-MF-000007044 · Hungary · Kiskunfélegyháza
Berkemann Hungary Bt. is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 32 |
|---|
Devices declared under this manufacturer
- Kalapácsujj-javítószalag éjszakára
- Kalapácsujj-korrigáló párna
- Kreuzbandage-M
- Kreuzbandage-S
- Kreuzbandage-XL
- Lábujjpárna lábujjfixálóval M-bal
- Lábujjpárna lábujjfixálóval S-bal
- Spreizfussbandage mit pelotte-XL
- Spreizfussbandage-S
- Spreizfussbandage-XL
- Valex D Hallux valgus − Nappali kötés M-Bal
- Valex D Hallux valgus − Nappali kötés S-Jobb
Showing 12 of 32 declared devices.
Catalogue references include 508154/002/632, 508154/002/642, 508157/002/990, 508310/002/630, 508330/002/640, 508330/002/660.
European nomenclature codes declared: Y061203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 32 |
| Country of registration | Hungary |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 32 |
|---|---|
| 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. Berkemann Hungary Bt. was not found in either the U.S. or the Canadian register.