Identity
- Trade Name
- SagiNova® Ir 25 channels, for Ir-192 only FDA UDI
- Generic Name
- Remote-afterloading brachytherapy system FDA UDI
- Device Name
- 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
- Model / Reference
- 06 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
- 1321-0202 FDA UDI
- Primary DI / UDI-DI
- 04065983000030 FDA UDI
- 510(k) Number
- K142986 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Remote-afterloading brachytherapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Remote-afterloading brachytherapy system
SagiNova® Ir 25 channels, for Ir-192 only by BEBIG Medical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Remote-afterloading brachytherapy system.
- MicroSelectron Digital — Nucletron B.V. · Class II
- VariSource iX — VARIAN MEDICAL SYSTEMS UK HOLDINGS LIMITED · Class II
- seedSelectron — Nucletron B.V. · Class II
- MicroSelectron Digital — Nucletron B.V. · Class II
- Bravos Afterloader System — Varian Medical Systems Deutschland GmbH · Class II
- Flexitron — Nucletron B.V. · Class II
- Flexitron — Nucletron B.V. · Class II
- Flexitron HDR — Nucletron B.V. · Class II
Cleared under the same submission
K142986 also covers:
- Disposable steel needle, 17G, L=200mm — BEBIG Medical GmbH
- Easy Click Transfer Tube 6F, D=3mm, L=1000mm — BEBIG Medical GmbH
- Easy Click Transfer Tube, D=3mm, L=1000mm — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Blue, Channel 3 — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Blue, Channel 3, T-connector — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Green, Channel 1 — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Green, Channel 1, T-connector — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, T-connector — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 2 — BEBIG Medical GmbH
- Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 2, T-connector — BEBIG Medical GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BEBIG Medical GmbH
Sources (2)
- FDA UDI 64f5dab0-2a18-4fe2-a00e-11643801373f 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026