Identity
- Trade Name
- 3D Brachy Application EUDAMEDFDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- Adaptiiv Software EUDAMED3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only. FDA UDI
- Model / Reference
- ADPT-3DBRACHY-POC EUDAMEDv2021.1.0 FDA UDI
- Description
- 3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007402326 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600074023SoftwareEK EUDAMED
- FDA Product Code
- MUJ FDA UDI
- EMDN Code
- Z11010392 BRACHYTHERAPY RADIATION SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
3D Brachy Application by Adaptiiv Medical Technologies, Inc. — Class I — 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 | 08600074023SoftwareEK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Adaptiiv Medical Technologies Inc.
- EUDAMED SRN
- CA-MF-000042710
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 35402584-8be4-46e5-a5c7-f35afd8859ef 61 fields · synced Sep 18, 2026
- FDA UDI c73fd37b-184f-4be5-91f3-34c52c76ccba 34 fields · synced May 30, 2026