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Sign in to claim this brandWhat Olympus Winter & Ibe GmbH makes
Olympus Winter & Ibe GmbH manufactures single-use and reusable endoscopic electrosurgical electrodes, including both bipolar and monopolar types, as well as reusable rigid endoscopic forceps for tissue manipulation. Their portfolio also includes reusable endoscope sheaths, obturators, and adaptors for endoscope assemblies, alongside dissection forceps designed for surgical precision.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Olympus Winter & Ibe GmbH manufacture?
Olympus Winter & Ibe GmbH specializes in endoscopic medical devices, including single-use and reusable electrosurgical electrodes (both bipolar and monopolar), reusable rigid endoscopic forceps for tissue manipulation, endoscope sheaths, obturators, endoscope assembly adaptors, and dissection forceps. These devices are designed for precision in surgical procedures, particularly within endoscopy.
Where is Olympus Winter & Ibe GmbH based?
The company is based in the United States. This location is relevant for regulatory compliance, manufacturing oversight, and distribution of their devices.
Which regulatory registries or databases list Olympus Winter & Ibe GmbH’s devices?
Olympus Winter & Ibe GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to identify and verify specific devices.
How are Olympus Winter & Ibe GmbH’s devices classified under FDA regulations?
The company’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- +1(800)401-1086
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 316957240
Catalogue (1203)
Page 6 of 25| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Olympus | WA22538S | FDA UDI | Class II | Active |
| Olympus | WA22538C | FDA UDI | Class II | Active |
| Olympus | WA22539S | FDA UDI | Class II | Active |
| Olympus | WA2UR31A | FDA UDI | Class II | Active |
| Olympus | WA69034L | FDA UDI | Class II | Unknown |
| Olympus | WA59381A | FDA UDI | Class II | Active |
| Olympus | WA96205A | FDA UDI | Class II | Active |
| Olympus | A70971A | FDA UDI | Class II | Active |
| Olympus | WA90300A | FDA UDI | Class II | Active |
| Olympus | WA47052C | FDA UDI | Class II | Unknown |
| Olympus | WA33028A | FDA UDI | Class II | Active |
| Olympus | WB990211 | FDA UDI | Class II | Active |
| Olympus | WA4KL500 | FDA UDI | Class II | Active |
| Olympus | A20977A | FDA UDI | Class II | Active |
| Olympus | A70942A | FDA UDI | Class II | Active |
| Olympus | WALP35MS | FDA UDI | Class II | Unknown |
| Olympus | 00110 | FDA UDI | Class II | Active |
| Olympus | WA69216M | FDA UDI | Class II | Unknown |
| Olympus | A64310A | FDA UDI | Class II | Active |
| Olympus | WA47056S | FDA UDI | Class II | Unknown |
| Olympus | WA64720L | FDA UDI | Class II | Active |
| Olmypus | A63310S | FDA UDI | Class II | Unknown |
| Olympus | WA63134A | FDA UDI | Class II | Unknown |
| Olympus | A64010S | FDA UDI | Class II | Active |
| Olympus | WA50015L | FDA UDI | Class II | Unknown |
| Olympus | WA70995A | FDA UDI | Class II | Active |
| Olympus | A70950A | FDA UDI | Class II | Active |
| Olmypus | A65320A | FDA UDI | Class II | Unknown |
| Olympus | WA22557S | FDA UDI | Class II | Active |
| Olmypus | WA63314A | FDA UDI | Class II | Unknown |
| Olympus | WA64330A | FDA UDI | Class II | Active |
| Olympus | A3557 | FDA UDI | Class II | Active |
| Olympus | A4559 | FDA UDI | Class II | Active |
| Olmypus | A63313S | FDA UDI | Class II | Unknown |
| Olympus | A63053A | FDA UDI | Class II | Unknown |
| Olympus | A64120A | FDA UDI | Class II | Active |
| Olympus | A64320A | FDA UDI | Class II | Active |
| Olympus | WA58385S | FDA UDI | Class II | Unknown |
| Olympus | A22043T | FDA UDI | Class II | Unknown |
| Olympus | A3408 | FDA UDI | Class II | Active |
| Olympus | WA51172A | EUDAMEDFDA UDI | Class II | Active |
| Olympus | A20712A | FDA UDI | Class II | Active |
| Olympus | WA05981A | FDA UDI | Class II | Active |
| Olympus | A37020A | FDA UDI | Class II | Active |
| Olympus | WA22640S | FDA UDI | Class II | Active |
| Olympus | WA69020M | FDA UDI | Class II | Unknown |
| Olympus | WA64710A | FDA UDI | Class II | Active |
| Olmypus | A66310A | FDA UDI | Class II | Active |
| Olympus | A7519 | FDA UDI | Class II | Active |
| Olympus | 00107 | FDA UDI | Class II | Active |
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