FDA Registration
Active
🇬🇧 United Kingdom
PENLON LTD.
Reg #: 9610531
·
FEI: 3002807907
·
Expires 2026
Products
6
Proprietary Names
23
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- PENLON LTD.
- Registration Number
- 9610531
- FEI Number
- 3002807907
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ABINGDON SCIENCE PARK, BARTON LANE
- City
- ABINGDON Oxfordshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K051222
Owner / Operator
- Firm Name
- PENLON LTD.
- Operator Number
- 9029886
- Address
- ABINGDON SCIENCE PARK, BARTON LANE
- City
- ABINGDON
- State
- GB-NOTA
- Postal Code
- OX14 3NB
- Country
- GB
US Agent
- Business Name
- DRE Resume, LLC
- Contact Name
- Brent Kramer
- Address
- 2601 Stanley Gault Pkwy Ste 101
- City
- Louisville
- State
- KY
- ZIP
- 40223
- Country
- US
- [email protected]
- Phone
- 502 2444444
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2003-03-17 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2007-11-19 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2002-04-24 |
| Vaporizer, Anesthesia, Non-Heated | CAD | Class 2 | Anesthesiology | No | 2007-11-19 |
| Gas-Machine, Anesthesia | BSZ | Class 2 | Anesthesiology | No | 2007-11-19 |
| Tube, Thorpe, Uncompensated | BYM | Class 1 | Anesthesiology | No | 2006-02-06 |
Proprietary Names
PENLON SUCTION CONTROLLER RANGE
AV-S MRI Anaesthesia Ventilator
AV-S Anaesthesia Ventilator
AV-S Anaesthesia Combined Ventilator
AV-S Anaesthesia Remote Ventilator
Penlon Crystal Metal Disposable Laryngoscope Handles & Bulbs
Penlon Diamond MRI Laryngoscope Blades, Handles & Bulbs
Penlon Green MRI Laryngoscope Blades, Handles & Bulbs
Penlon Diamond Laryngoscope Blades, Handles & Bulbs (Green)
PENLON LARYNGOSCOPE RANGE
Sigma Delta Keyed Filler Bottle Adapter
Keyed Filler Bottle Adaptor Isoflurane
Keyed Filler Bottle Adaptor Halothane
Keyed Filler Bottle Adaptor Sevoflurane
Quik-Fil Vaporizer Keyed Filler
Prima 450
Prima 451 MRI
Prima 440
Prima 445
Prima 460
SIGMA DELTA MRI VAPORIZER
SIGMA DELTA VAPORIZER
Oxygen Therapy Flowmeters
Establishment Types
Manufacture Medical Device