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Orthopantomograph™ Op 3d
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 900991Model PCX-1Ref 901001Model OP300-1
Identity
- Trade Name
- ORTHOPANTOMOGRAPH™ OP 3D EUDAMEDORTHOPANTOMOGRAPH™ OP 3D Pro EUDAMEDORTHOPANTOMOGRAPH OP 3D Pro FDA UDIORTHOPANTOMOGRAPH OP 3D FDA UDI
- Generic Name
- Limited-view-field CT system FDA UDI
- Device Name
- ORTHOPANTOMOGRAPH™ OP 3D EUDAMEDORTHOPANTOMOGRAPH™ OP 3D Pro EUDAMEDORTHOPANTOMOGRAPH OP 3D (pan/cbct) FDA UDI
- Model / Reference
- PCX-1 EUDAMEDFDA UDI900991 EUDAMEDOP300-1 EUDAMEDFDA UDI901001 EUDAMED
- Description
- ORTHOPANTOMOGRAPH OP 3D (pan/cbct) FDA UDI
Identifiers
- Catalog Number
- 901001 FDA UDI900991 FDA UDI
- Primary DI / UDI-DI
- 06430035872688 EUDAMEDFDA UDI06430035872725 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430035872688 EUDAMEDB-06430035872725 EUDAMED643003587OP3D9A EUDAMED
- 510(k) Number
- K133544 FDA UDI
- FDA Product Code
- OAS FDA UDI
- EMDN Code
- Z11030507 TOMOGRAPHS EUDAMED
- GMDN Term
- Limited-view-field CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Orthopantomograph™ Op 3d by PaloDEx Group Oy — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06430035872688 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06430035872688 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- PaloDEx Group Oy
- EUDAMED SRN
- FI-MF-000004943
Sources (5)
- EUDAMED fca06603-a993-4ddf-9f39-4afb8f3065f9 61 fields · synced Sep 17, 2026
- EUDAMED 18a74eef-f0a7-43de-a0b0-75cb548305c8 61 fields · synced May 18, 2026
- FDA UDI 5490c5ae-845b-478b-9573-c6e13dc95c66 35 fields · synced May 30, 2026
- FDA UDI 11a3bf24-92b3-49b3-ba4f-9f0bb5aefb52 35 fields · synced May 30, 2026
- EUDAMED 76b4ce46-36ae-4dd4-93e0-760010990d29 61 fields · synced Jul 19, 2026