BEBIG Medical GmbH devices, product family

by BEBIG Medical GmbH 9 variants Basic UDI-DI 40659830002BC3

Shared by every variant

Manufacturer: BEBIG Medical GmbH(9)
Basic UDI-DI: 40659830002BC3
Risk class: Class IIbClass II (varies)
Legislation: MDR
EMDN category: BRACHYTHERAPY RADIATION SYSTEMS - MEDICAL DEVICE SOFTWARE
Market status: 9 on the market
Official record: EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 40659830002BC3.

1 certificate naming this Basic UDI-DI · EUDAMED

2259103CE01 Quality management system · refdata.applicable-legislation.mdr supplemented
Notified body 0344 · holder BEBIG Medical GmbH · issued 1 May 2024 · expires 16 Nov 2028

1 recall · 1 ongoing · FDA

Z-0517-2024 Class II · ongoing · 17 Oct 2023
Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.

Recalls matched to the 9 devices listed on this page; other pages of the family can carry others.

9 devices · page 1 of 1

Variants of BEBIG Medical GmbH devices, Basic UDI-DI 40659830002BC3
		UDI-DI	Size and differences
SagiPlan®	1374-0600	04065983000016	—	On the market
SagiPlan® TPS - Prostate Module, preconfigured Notebook EN	1374-0631	04065983000085	—	On the market
SagiPlan® TPS - Prostate Module, preconfigured Notebook FR	1374-0632	04065983000092	—	On the market
SagiPlan® Treatment Planning System, preconfigured Desktop PC	1374-0620	04065983000054	—	On the market
SagiPlan® Treatment Planning System, preconfigured Notebook EN	1374-0621	04065983000061	—	On the market
SagiPlan® Treatment Planning System, preconfigured Notebook FR	1374-0622	04065983000078	—	On the market
SagiPlan® with prostate module 06	1374-0610 / 06	04065983000047	—	On the market
Upgrade Fee to SagiPlan® 2.x	1374-0640	04065983000108	—	On the market
Upgrade Fee to SagiPlan® 2.x incl. Prostate Module	1374-0650	04065983000115	—	On the market