APOLLO IMPLANT COMPONENTS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
PL-MF-000023711 · Poland · Pabianice
APOLLO IMPLANT COMPONENTS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 298 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 297 |
|---|---|
| Class IIb | 1 |
Devices declared under this manufacturer
- Alpha™ Scanbody 3.5Single-wing C
- Alpha™ Scanbody 4.8 Double-wing E
- Alpha™ Scanbody 4.8 Single-wing A
- Alpha™ Scanbody 4.8 Single-wing B
- Laboratory Screw Multi-unit multiSHIFT36° / C-Tech Multiunit
- SmartFlag by APOLLO
- SmartFlag by APOLLO Multi-Unit A
- SmartFlag by APOLLO Multi-Unit B
- SmartFlag by APOLLO Multi-Unit C
- SmartFlag by APOLLO Multi-Unit D
- SmartFlag by APOLLO Multi-Unit E
- SmartFlag by APOLLO Multi-Unit F
Showing 12 of 298 declared devices.
Catalogue references include 004.1S10.A-006-M42, 004.1S10.B-009-02, 004.1S10.B-012-M48, 004.2S5.E-010-M51, 004.2S5.F-013-M45, 004.2S5.F-053-M50.
European nomenclature codes declared: Q010207, Q010280, P01020101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 298 |
| 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 | 298 |
|---|---|
| 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. APOLLO IMPLANT COMPONENTS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 2607846-1 | supplemented | 2028-12-19 |