PaloDEx Group Oy
FI-MF-000004943 · Finland · Tuusula
PaloDEx Group Oy is registered in the European database on medical devices as a manufacturer, with 98 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 74 |
|---|---|
| Class IIb | 24 |
Most frequent device types declared: 11.x, 6.x, DXR-50, DXR-60, Focus.
Among these devices, 30 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- BITE BLOCK DISPOSABLE COVER ROLL
- Comfort Occlusal Hygiene Bags for occlusal projection images, size 4C,
- DIGORA™ Optime
- HYGIENE BAG SIZE 0 200 PCS
- IDOT IP SET S1 X 6 SCAN EXAM TYPE
- Nasion Support Disposable Cover
- OCCLUSAL 4C KIT SCAN EXAM
- OPTIBAG SIZE 3 200PCS
- ORTHOPANTOMOGRAPH™ OP 3D
- ORTHOPANTOMOGRAPH™ OP 3D Pro
- STD IP SET 1X2, 2X2 DT-1
- STD IP SET S2 X 6 OPTIME TYPE
Showing 12 of 98 declared devices.
Catalogue references include 6801120-SDX, 900186-PTU, 900511-DEX, 900606, 900687-PTU, 900801-DEX.
European nomenclature codes declared: Z11030485, Z1103040102, Z11030507, Z11030585, Z11030392, Z11030580.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PALODEX GROUP OY (FI) · FDA 3005383085 |
| Devices in EUDAMED | 98 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 98 |
|---|---|
| Found in the U.S. device database | 88 |
| Share | 89.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PALODEX GROUP OY |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 4 |
| First licensed | 2002-03-11 |
Licence types: Device Family (3), Device Group Family (2), System (1).
Licensed under: FOCUS DENTAL X-RAY SYSTEM, DIGORA OPTIME, OP300(ORTHOPANTOMOGRAPH) PANORAMIC, OP300(ORTHOPANTOMOGRAPH) WITH 3D FOV SIZES, ORTHOPANTOMOGRAPH OP 3D, ORTHOPANTOMOGRAPH OP 3D LX.
North American profile: Both markets. PaloDEx Group Oy is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1154-812-23 | supplemented | 2028-03-06 |