Bonalive Ltd
FI-MF-000001174 · Finland · Turku
Bonalive Ltd is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 19 |
|---|
Most frequent device types declared: Ref: 13110, 1 x 1 cc in small applicator, Ref: 13120, 1 x 2.5 cc in small applicator, Ref: 13330, 1 x 5 cc in large applicator, Ref: 13340, 1 x 10 cc in large applicator, Ref: 13430, 1 x 5 cc in large applicator.
Among these devices, 19 are declared sterile, 19 implantable.
Devices declared under this manufacturer
- Bonalive® granules
- Bonalive® granules CMF
- Bonalive® putty
- Bonalive® putty MIS
- Bonalive® putty MIS 2 cc
Showing 12 of 19 declared devices.
Catalogue references include 13120, 13330, 13340, 13430, 16110, 18100.
European nomenclature codes declared: P900402.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BONALIVE LTD (FI) · FDA 3008328709 |
| Devices in EUDAMED | 19 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 19 |
|---|---|
| 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: United States only. Bonalive Ltd is registered in the United States but was not found in the Canadian register.