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Orthopantomograph™ Op 3d
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 901085Model PCX-1
Identity
- Trade Name
- ORTHOPANTOMOGRAPH™ OP 3D EUDAMEDOrthopantomograph OP 3D FDA UDI
- Generic Name
- Limited-view-field CT system FDA UDI
- Device Name
- ORTHOPANTOMOGRAPH™ OP 3D EUDAMED
- Model / Reference
- PCX-1 EUDAMED901085 EUDAMED3D upgrade kit for OP 3D FDA UDI
Identifiers
- Catalog Number
- 901085 FDA UDI
- Primary DI / UDI-DI
- 06430035873630 EUDAMEDFDA UDI
- Basic UDI-DI
- 643003587OP3D9A EUDAMED
- 510(k) Number
- K180947 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
No
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, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 643003587OP3D9A | 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 b5379ba6-c07e-4dd6-a789-0a8506c615c7 61 fields · synced Jul 30, 2026
- FDA UDI cc8ca86f-23fc-45f3-b977-d53d55a26cdc 34 fields · synced May 30, 2026