FDA Registration
Active
🇩🇪 Germany
Olympus Winter & Ibe GmbH
Reg #: 3003724334
·
FEI: 3003724334
·
Expires 2026
Products
8
Proprietary Names
24
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Olympus Winter & Ibe GmbH
- Registration Number
- 3003724334
- FEI Number
- 3003724334
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Berlin facility, Rheinstrasse 8
- City
- TELTOW Brandenburg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K203682
Owner / Operator
- Firm Name
- OLYMPUS CORPORATION
- Operator Number
- 9067818
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI
- State
- Tokyo
- Postal Code
- 192-8507
- Country
- JP
US Agent
- Business Name
- Gyrus ACMI, Inc.
- Contact Name
- Todd Brill
- Address
- 800 West Park Drive, --
- City
- Westborough
- State
- MA
- ZIP
- 01581
- Country
- US
- [email protected]
- Phone
- 508 2077661
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-07-13 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2023-11-07 |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | Class 2 | Obstetrics/Gynecology | No | 2014-06-09 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2014-06-09 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2012-02-13 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2012-02-13 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2008-06-17 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2008-06-17 |
Proprietary Names
ESG-400
Electrosurgical Generator ESG-410 and Accessories
WA91302W
WA91307W
WA91303W
WA91301W
PK-CF0533
WA91307C
Versapoint
CELON ENT SYSTEM
Pressure Reducer
ESG-300
MAPC Probes
ESG-150
CELON ELITE ESG-200
MAJ-1870
MAJ-1869
ESG-100, AFU-100
MAJ-1873
MAJ-1872
MAJ-1871
MAJ-1876
WB990310; WB990311; WB990210;WB990211
WA50021B; WA50023B; WA50023S
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility