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Segment 3DPrint
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 07350010100041
by Medviso AB
Identity
- Trade Name
- Segment 3DPrint EUDAMEDFDA UDI
- Generic Name
- Image segmentation application software FDA UDI
- Device Name
- Segment 3DPrint EUDAMED
- Model / Reference
- 07350010100041 EUDAMED1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350010100041 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07350010100041 EUDAMED073500101000417A EUDAMED
- Direct Marketing DI
- 07350010100041 EUDAMED
- 510(k) Number
- K211966 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z129092 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Image segmentation application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Market of Registration
- Sweden EUDAMEDGermany 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Segment 3DPrint by Medviso AB — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090833 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K211966 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-07350010100041 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07350010100041 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medviso AB
- EUDAMED SRN
- SE-MF-000003217
Sources (4)
- EUDAMED 58a5b596-cdb0-4b01-99cf-323f3ab7fb7d 61 fields · synced Jul 31, 2026
- EUDAMED 25a37738-4545-4d3e-95e9-a7e1e3664da4 61 fields · synced May 19, 2026
- FDA UDI 88d3f1db-cfc3-498f-a4db-2cf54eb8c013 33 fields · synced May 30, 2026
- FDA 510(k) K090833 1 fields · synced May 18, 2026