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Planmeca ProX
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 10029551Ref 10029551
by Planmeca Oy
Identity
- Trade Name
- Planmeca Intra FDA UDI
- Generic Name
- Stationary intraoral dental x-ray system, digital FDA UDI
- Device Name
- Planmeca ProX EUDAMEDPlanmeca ProX is an X-ray source to produce intraoral X-ray images for the diagnosis of teeth and adjacent structures. FDA UDI
- Model / Reference
- 10029551 EUDAMEDProX FDA UDI
- Description
- Planmeca ProX is an X-ray source to produce intraoral X-ray images for the diagnosis of teeth and adjacent structures. FDA UDI
Identifiers
- Catalog Number
- 10029551, 30054728, 30054748, 30054749, 30054750, 30061112, 30061673 FDA UDI
- Primary DI / UDI-DI
- 06430035420360 EUDAMEDFDA UDI
- Basic UDI-DI
- 6430035420095V EUDAMEDB-06430035420360 EUDAMED
- FDA Product Code
- EHD FDA UDI
- EMDN Code
- Z1103040101 EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary intraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 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
Yes
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
Planmeca ProX by Planmeca Oy — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6430035420095V | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 6430035420095V | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Planmeca Oy
- EUDAMED SRN
- FI-MF-000006499
Sources (3)
- EUDAMED 8579c11a-5c6c-4065-8944-823a9571984e 61 fields · synced Jul 18, 2026
- EUDAMED 5cb48257-f492-457c-8de4-9fa3e1620d53 61 fields · synced May 19, 2026
- FDA UDI 278a67bc-ce9c-496d-a656-d4bf10a39331 34 fields · synced May 29, 2026