Identity
- Trade Name
- SagiPlan® EUDAMEDFDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- SagiPlan® EUDAMEDSagiPlan® is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan® is used for the creation of treatment plans for remote afterloader based HDR brachytherapy. SagiPlan® will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan® also supports the evaluation of clinical images in calculating the dose for organs at risk and target volumes. SagiPlan® especially supports the SagiNova (Multisource and GyneSource) Brachytherapy Remote Controlled Afterloading Devices from BEBIG Medical GmbH (Eckert & Ziegler BEBIG GmbH). FDA UDI
- Model / Reference
- 1374-0600 EUDAMED06 FDA UDI
- Description
- SagiPlan® is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan® is used for the creation of treatment plans for remote afterloader based HDR brachytherapy. SagiPlan® will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan® also supports the evaluation of clinical images in calculating the dose for organs at risk and target volumes. SagiPlan® especially supports the SagiNova (Multisource and GyneSource) Brachytherapy Remote Controlled Afterloading Devices from BEBIG Medical GmbH (Eckert & Ziegler BEBIG GmbH). FDA UDI
Identifiers
- Catalog Number
- 1374-0600 FDA UDI
- Primary DI / UDI-DI
- 04065983000016 EUDAMEDFDA UDI
- Basic UDI-DI
- 40659830002BC3 EUDAMED
- Direct Marketing DI
- 04065983000016 EUDAMED
- 510(k) Number
- K141900 FDA UDI
- 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 IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
SagiPlan® by BEBIG Medical GmbH — 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 | 40659830002BC3 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- BEBIG Medical GmbH
- EUDAMED SRN
- DE-MF-000012644
Sources (2)
- EUDAMED 1213b7f7-a2b6-46bc-b2ea-6e7adcaf8616 61 fields · synced Jun 18, 2026
- FDA UDI 18cf4524-ea94-489b-ace7-89ece4417413 36 fields · synced May 30, 2026