FDA Registration
Active
🇬🇧 United Kingdom
KEYMED (Medical & Industrial Equipment) Ltd
Reg #: 9611174
·
FEI: 1000162602
·
Expires 2026
Products
8
Proprietary Names
35
Establishment Types
4
Classifications
8
Registration Details
- Registration Name
- KEYMED (Medical & Industrial Equipment) Ltd
- Registration Number
- 9611174
- FEI Number
- 1000162602
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- KeyMed House, Stock Road
- City
- SOUTHEND-ON-SEA Essex
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K162205
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 |
|---|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2023-10-20 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2023-10-20 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2008-03-03 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2023-10-20 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2013-01-09 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2023-10-20 |
| Extractor, Vacuum, Fetal | HDB | Class 2 | Obstetrics/Gynecology | No | 2023-10-20 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2016-02-23 |
Proprietary Names
MAJ-1651
MAJ-1681
MAJ-1606
MAJ-1603
MAJ-1607
OFP-2
MAJ-1608
MAJ-1652
MAJ-1682
FTL-DEK-B
BW-400V
BW-403B
MAJ-1339
BW-400B
BW-411B
BW-412T
MAJ-1888
BW-400L
Cleaning Accessory
FTL-DEK-A
Single Use Cleaning Brush
MAJ-683
TC-E300
WM-DP3
TC-C4
WM-NP3
MAJ-684
TC-L
TC-C3
TC-E400
MA-651
MAJ-1632
MB-142
MA-392
MA-474
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device