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3mensio Workstation
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10.0Model 3mensio Workstation
Identity
- Trade Name
- 3mensio Workstation EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- 3mensio Workstation 10.0 EUDAMEDDevelopment ongoing FDA UDI
- Model / Reference
- 3mensio Workstation EUDAMED10.0 EUDAMEDFDA UDI
- Description
- Development ongoing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304454072 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08056304454072 EUDAMED
- 510(k) Number
- K153736 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
3mensio Workstation by Pie Medical Imaging B.v. — Class IIa — 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-08056304454072 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Pie Medical Imaging B.V.
- EUDAMED SRN
- NL-MF-000001540
Sources (2)
- EUDAMED d101e383-b772-4c71-804b-6ad9d392edaa 61 fields · synced Jul 11, 2026
- FDA UDI ec5bd625-be40-4a31-a342-ed4971c663c4 35 fields · synced May 30, 2026