Identity
- Trade Name
- SagiNova® EUDAMEDSagiNova® 25 channels, for Co-60 and Ir-192 FDA UDI
- Generic Name
- Remote-afterloading brachytherapy system FDA UDI
- Device Name
- SagiNova® EUDAMEDSagiNova® is a family of BEBIG Medical (and Eckert & Ziegler BEBIG) HDR afterloading systems that are intended to apply brachytherapy treatment to specific body sites (interstitial, intracavitary, intraluminal, and intra-operative or skin surface) with a remote-controlled radioactive source. The systems are intended to be used by medical professionals trained in radiation oncology. FDA UDI
- Model / Reference
- 1321-0201 EUDAMED06 FDA UDI
- Description
- SagiNova® is a family of BEBIG Medical (and Eckert & Ziegler BEBIG) HDR afterloading systems that are intended to apply brachytherapy treatment to specific body sites (interstitial, intracavitary, intraluminal, and intra-operative or skin surface) with a remote-controlled radioactive source. The systems are intended to be used by medical professionals trained in radiation oncology. FDA UDI
Identifiers
- Catalog Number
- 1321-0201 FDA UDI
- Primary DI / UDI-DI
- 04065983000023 EUDAMEDFDA UDI
- Basic UDI-DI
- 40659830001BBY EUDAMED
- Direct Marketing DI
- 04065983000023 EUDAMED
- 510(k) Number
- K142986 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010301 BRACHYTHERAPY RADIATION SYSTEMS EUDAMED
- GMDN Term
- Remote-afterloading brachytherapy system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Spain 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SagiNova® 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 | 40659830001BBY | 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 fed96969-3089-445f-87d9-d4459d54f20a 61 fields · synced May 31, 2026
- FDA UDI 189b9d52-3750-4b39-bd76-afdbeb3b2ec6 35 fields · synced May 26, 2026