BEBIG Medical GmbH
DE-MF-000012644 · Germany · Berlin
BEBIG Medical GmbH is registered in the European database on medical devices as a manufacturer, with 95 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 83 |
|---|---|
| Class IIb | 12 |
Most frequent device types declared: SagiStar® C, SagiStar® E.
Among these devices, 6 are declared sterile, 12 active.
Devices declared under this manufacturer
- 2-Channel-Ring-Applicator CT/MR, 60°, D=25mm
- 2-Channel-Ring-Applicator CT/MR, 60°, D=30mm
- 2-Channel-Ring-Applicator, 60°, d=30mm; Type Vienna, 0°
- CT/MR Holding Discs for gyn. Applicator, d=3.5mm D=15mm
- CT/MR-Vag. Cylinder with variable length D=12.5mm L=120mm
- CT/MR-Vag. Cylinder with variable length D=15mm L=120mm
- Hollow Needle for flexible Catheter, 18G, L=200mm
- IU Tube for Ring-Applicator CT/MR, 60°, IUL=20mm, coloured
- IU Tube for Ring-Applicator CT/MR, 60°, IUL=40mm, coloured
- Ovoid Pair, D=30mm, L=30mm (à 2 pc)
- Shielding Segment 180°
- Transfer Tube, D=3mm, L=1000mm
Showing 12 of 95 declared devices.
Catalogue references include LA320-89, LAF1000, LAF1000-1, LCT42-1, LCT42-6, LCT42-7.
European nomenclature codes declared: Z11010380, Z11010392, A019016,Z11010385, Z11010301, Z11010101, Z11010102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BEBIG MEDICAL GMBH (DE) · FDA 3019543601 |
| Devices in EUDAMED | 95 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 95 |
|---|---|
| Found in the U.S. device database | 16 |
| Share | 16.8 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. BEBIG Medical GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2259103CE01 | supplemented | 2028-11-16 |
2025-MDR/QS-083/A | amended | 2030-12-15 |