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ORTHOPANTOMOGRAPH™ OP 3D Pro
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 901004Model OP300-1
Identity
- Trade Name
- ORTHOPANTOMOGRAPH™ OP 3D Pro EUDAMEDORTHOPANTOMOGRAPH OP 3D Pro FDA UDI
- Generic Name
- Limited-view-field CT system FDA UDI
- Device Name
- ORTHOPANTOMOGRAPH™ OP 3D Pro EUDAMED
- Model / Reference
- OP300-1 EUDAMEDFDA UDI901004 EUDAMED
Identifiers
- Catalog Number
- 901004 FDA UDI
- Primary DI / UDI-DI
- 06430035872756 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430035872756 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 Pro by PaloDEx Group Oy — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06430035872756 | 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 (2)
- EUDAMED 50c3b539-662e-4f1c-bf80-2d8936c044ce 61 fields · synced Jul 19, 2026
- FDA UDI 2c70fd6b-f250-4dd2-ac64-56efea57e3fc 35 fields · synced May 30, 2026