Manufacturer

BEBIG Medical

GermanyLegal entities : BEBIG Medical GmbH

Markets : France · Germany · Spain · Türkiye · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – · class II

Public contracts won : France 1

Website sales@bebigmedical.com

3 categories, 67 models including 67 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Brachytherapy radiation systems - hardware accessories	Z11010380	2-Channel-Ring-Applicator CT/MR, 30°, D=25mm93/42 2-Channel-Ring-Applicator CT/MR, 30°, D=30mm93/42 2-Channel-Ring-Applicator CT/MR, 30°, D=35mm93/42 2-Channel-Ring-Applicator CT/MR, 45°, D=25mm93/42 2-Channel-Ring-Applicator CT/MR, 45°, D=30mm93/42 60 others 2-Channel-Ring-Applicator CT/MR, 45°, D=35mm93/42 2-Channel-Ring-Applicator CT/MR, 60°, D=25mm93/42 2-Channel-Ring-Applicator CT/MR, 60°, D=30mm93/42 2-Channel-Ring-Applicator CT/MR, 60°, D=35mm93/42 2-Channel-Ring-Applicator, 60°, d=30mm; Type Vienna, 0° 2-Channel-Ring-Applicator 60° Type Vienna93/42 2-Channel-Ring-Applicator, 60°, d=30mm; Type Vienna, 5° 2-Channel-Ring-Applicator 60° Type Vienna93/42 Adapter for Vaginal Cylinder93/42 Applicator Clamp with Base Plate LAZ22-01 Connector for Universal Applicator, D=2.0mm (EasyClick 6F) CT/MR Cap, closed, D=25mm93/42 CT/MR Cap, closed, D=30mm93/42 CT/MR Cap, open, D=25mm93/42 CT/MR Cap, open, D=30mm93/42 CT/MR Endometrium Applicator, D=3.5mm93/42 CT/MR Fletcher Ovoid Tubes right and left, colour-coded93/42 CT/MR Holding Discs for gyn. Applicator, d=3.5mm D=15mm93/42 CT/MR Intrauterine Tube 15° D=3.5mm IUL=25mm coloured93/42 CT/MR Intrauterine Tube 20° D=3.5mm IUL=30mm coloured93/42 CT/MR Intrauterine Tube 25° D=3.5mm IUL=35mm coloured93/42 CT/MR Intrauterine Tube 30° D=3.5mm IUL=65mm coloured93/42 CT/MR Intrauterine Tube 40° D=3.5mm IUL=35mm coloured93/42 CT/MR Intrauterine Tube straight thin D=3.5mm coloured93/42 CT/MR Rectal Retractor LCZ50-0193/42 CT/MR-Vag. Cylinder with variable length D=12.5mm L=120mm93/42 CT/MR-Vag. Cylinder with variable length D=15mm L=120mm93/42 CT/MR-Vag. Cylinder with variable length D=20mm L=120mm93/42 CT/MR-Vag. Cylinder with variable length D=25mm L=125mm93/42 CT/MR-Vag. Cylinder with variable length D=30mm L=130mm93/42 CT/MR-Vag. Cylinder with variable length D=35mm L=135mm93/42 CT/MR-Vag. Cylinder with variable length D=40mm L=140mm93/42 CT/MR-Vaginal Cylinder, Cervix; D=20mm, L=130mm93/42 CT/MR-Vaginal Cylinder, Cervix; D=25mm, L=130mm93/42 CT/MR-Vaginal Cylinder, Cervix; D=30mm, L=130mm93/42 Easy Click Transfer Tube 6F, D=3mm, L=1000mm3 refs Fixation Ball, d=1.62mm, D=7mm (à 10 pc)93/42 Fixation Ball, d=1.6mm, D=7mm (à 10 pc)93/42 Fixation cap d=1.63 refs Fixation Tube, D=5mm93/42 Flexible Obturator for 300mm plastic needles, D=1.1mm3 refs IU Tube for Ring-Applicator CT/MR, 30°, IUL=20mm93/42 IU Tube for Ring-Applicator CT/MR, 30°, IUL=40mm93/42 IU Tube for Ring-Applicator CT/MR, 30°, IUL=60mm93/42 IU Tube for Ring-Applicator CT/MR, 45°, IUL=20mm93/42 IU Tube for Ring-Applicator CT/MR, 45°, IUL=40mm93/42 IU Tube for Ring-Applicator CT/MR, 45°, IUL=60mm93/42 IU Tube for Ring-Applicator CT/MR, 60°, IUL=20mm, coloured93/42 IU Tube for Ring-Applicator CT/MR, 60°, IUL=40mm, coloured93/42 IU Tube for Ring-Applicator CT/MR, 60°, IUL=60mm, coloured93/42 IU Tube for Ring-Applicator CT/MR, D=3.5mm L=60mm93/42 Mini-Ovoid Pair, D=15mm, L=30mm (à 2 pc)93/42 Ovoid Pair, D=20mm, L=30mm (à 2 pc)93/42 Ovoid Pair, D=25mm, L=30mm (à 2 pc)93/42 Ovoid Pair, D=30mm, L=30mm (à 2 pc)93/42 Receptor for Shielding Segments93/42 Shielding Segment 180°93/42 Shielding Segment 90°93/42 Vaginal Cylinder, closed, D=22mm, L=130mm93/42 Vaginal Cylinder, closed, D=25mm, L=130mm93/42 Vaginal Cylinder, closed, D=30mm, L=130mm93/42 Vaginal Cylinder, closed, D=35mm, L=130mm93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Brachytherapy radiation systems	Z11010301	SagiNova®	IIb MDR	EUDAMED record Report an error
Brachytherapy radiation systems - medical device software	Z11010392	SagiPlan®3 refs	IIb MDR	EUDAMED record Report an error

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