Olympus Winter & Ibe GmbH
DE-MF-000006729 · Germany · Hamburg
Olympus Winter & Ibe GmbH is registered in the European database on medical devices as a manufacturer, with 238 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 123 |
|---|---|
| Class IIb | 115 |
Among these devices, 4 are declared reusable, 119 active.
Devices declared under this manufacturer
- Adapter Fujifilm 1
- Adapter OLY CS-EUS1
- Adapter Olympus 1
- Electrosurgical generator ESG-400
- Foot switch
- Foot switch double pedal
- Instrument tray
- Jaws insert, 5 x 250, DeBakey, monopolar HICURA
- Jaws insert, 5 x 330, Johann single action, monopolar HICURA
- Jaws insert, 5 x 330, atraumatic, monopolar HICURA
- Leakage tester, for flexible Olympus endoscopes
- Light source , for stroboscopy OLYMPUS CLL-S1
Showing 12 of 238 declared devices.
Catalogue references include WA23080A, WA51138A, WA69312M, WA69318S, WA91301W, WA97010A.
European nomenclature codes declared: L180402, Z12011380, Z12020701, Z12010905, Z12020402, L180202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OLYMPUS WINTER & IBE GMBH (DE) · FDA 9610773 |
| Devices in EUDAMED | 238 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 238 |
|---|---|
| Found in the U.S. device database | 164 |
| Share | 68.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OLYMPUS WINTER & IBE GMBH |
What it holds in Canada
| Licences on record | 80 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 71 |
| Class 3 devices | 9 |
| First licensed | 2003-08-01 |
Licence types: Device Family (54), System (12), Single Device (10), Device Group Family (2).
Licensed under: KNIFE, CELONLAB ENT, THROAT MICROPHONE, TELESCOPE "ULTRA", HIQ+ NEEDLE HOLDER, VMC-3 CONTROL UNIT.
North American profile: Both markets. Olympus Winter & Ibe GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1845129-1 | supplemented | 2025-04-20 |
HZ 1845129-1 | supplemented | 2030-04-20 |