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Sign in to claim this brandWhat Penlon , Ltd. makes
Penlon, Ltd. manufactures reusable laryngoscope blades and handles, as well as vacuum suction regulators designed for general-purpose medical use. Their portfolio also includes anaesthesia vaporizers for sevoflurane and isoflurane, portable pneumatic ventilators, and reusable anaesthesia breathing circuits. Additionally, they produce general-purpose multi-parameter bedside monitors for patient monitoring.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions documented through 510(k) clearances and UDI registrations. These products are listed under FDA oversight in the United States, where the manufacturer is based.
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 Penlon, Ltd. primarily manufacture?
Penlon, Ltd. specializes in reusable medical devices for anaesthesia and patient monitoring. Their core products include laryngoscope blades and handles, vacuum suction regulators for general medical use, and reusable anaesthesia breathing circuits. They also manufacture anaesthesia vaporizers for sevoflurane and isoflurane, portable pneumatic ventilators, and general-purpose multi-parameter bedside monitors. These devices support critical functions in operating rooms and intensive care settings.
Where is Penlon, Ltd. based, and which regulatory registries list its devices?
Penlon, Ltd. is based in the United States. Their devices are listed under FDA oversight, with regulatory submissions documented through 510(k) clearances and Unique Device Identifier (UDI) registrations. This means their products appear in the FDA’s 510(k) and UDI databases, ensuring compliance with U.S. medical device regulations.
How are Penlon, Ltd.’s devices classified under FDA regulations?
Penlon, Ltd.’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose the lowest risk and often require less regulatory oversight, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact, as outlined in FDA guidelines.
What is the purpose of the vacuum suction regulators and multi-parameter monitors produced by Penlon, Ltd.?
Penlon’s vacuum suction regulators are designed for general-purpose medical use, ensuring controlled aspiration during surgical and diagnostic procedures to maintain clear airways and reduce infection risks. Their multi-parameter bedside monitors provide real-time patient data, such as heart rate, blood pressure, and oxygen levels, enabling continuous assessment in critical care environments. Both devices support essential clinical functions in patient safety and procedural efficiency.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- penlon.com
- —
- —
- [email protected]
- Phone
- 800-328-6216
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 458942687
Catalogue (84)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Penlon | 408001025 | FDA UDI | Class I | Active |
| Penlon | 408001017 | FDA UDI | Class I | Active |
| Penlon | ISO ‘Green’ System Diamond Fibrelight Blade Set 1 & 2 | FDA UDI | Class I | Active |
| Penlon | 9510-026-4M | FDA UDI | Class II | Active |
| Penlon | 408001014 | FDA UDI | Class I | Active |
| Penlon | ISO ‘Red’ System Premier Fibrelight Blade | FDA UDI | Class I | Active |
| Penlon | Nuffield 200 MRI | FDA UDI | Class II | Active |
| SC760 MRI Suction Controller 2m hose | SC760 MRI | FDA UDI | Class II | Active |
| Key Filler Bottle Adaptor MRI | Key Filler Bottle Adaptor MRI | FDA UDI | Class II | Active |
| Penlon | 408001011 | FDA UDI | Class I | Active |
| Penlon | 53450 | FDA UDI | Class II | Active |
| Penlon | 408001022 | FDA UDI | Class I | Active |
| Penlon | Crystal Metal Disposable Blade | FDA UDI | Class I | Active |
| Penlon | 408001012 | FDA UDI | Class I | Active |
| Penlon | McCoy laryngoscope Blade, Handle | FDA UDI | Class I | Active |
| Penlon | 9510-026 | FDA UDI | Class II | Active |
| Penlon | 408001004 | FDA UDI | Class I | Active |
| Penlon | Premier Conventional Handle | FDA UDI | Class I | Active |
| Penlon | 310104 | FDA UDI | Class II | Active |
| A200SP Absorber MRI | A200SP | FDA UDI | Class I | Active |
| Penlon | 54909 | FDA UDI | Class II | Active |
| Penlon | 5007494 | FDA UDI | Class II | Active |
| Penlon | Sigma Delta | FDA UDI | Class II | Unknown |
| Penlon | 53453 | FDA UDI | Class II | Active |
| Penlon | ISO ‘Green’ System MRI Blade | FDA UDI | Class I | Active |
| Penlon | 408001007 | FDA UDI | Class I | Active |
| Penlon | 310107 | FDA UDI | Class II | Active |
| Penlon | 9510-025 | FDA UDI | Class II | Active |
| Penlon | Diamond Fibrelight ISO ‘Green’ type Handle | FDA UDI | Class I | Active |
| Penlon | 53454 | FDA UDI | Class II | Active |
| Penlon | 408001016 | FDA UDI | Class I | Active |
| Penlon | ISO ‘Green’ System Diamond Fibrelight Blade | FDA UDI | Class I | Active |
| Penlon | 310005 | FDA UDI | Class II | Active |
| Penlon | AV-S Remote | FDA UDI | Class II | Active |
| Penlon | 310105-0.5M | FDA UDI | Class II | Active |
| Penlon | 408001008 | FDA UDI | Class I | Active |
| Penlon | 408001015 | FDA UDI | Class I | Active |
| Penlon | 9910-244 | FDA UDI | Class II | Active |
| Penlon | 310105 | FDA UDI | Class II | Active |
| Penlon | Crystal Metal Disposable Handle | FDA UDI | Class I | Active |
| Penlon | Nuffield 200 | FDA UDI | Class II | Active |
| Penlon | 310106 | FDA UDI | Class II | Active |
| Penlon | 408001001 | FDA UDI | Class I | Active |
| Penlon | 408001004 | FDA UDI | Class I | Unknown |
| Penlon | Premier Conventional Blade | FDA UDI | Class I | Active |
| AnaVue 4000 Patient Monitor | AnaVue 4000 | FDA UDI | Class II | Active |
| Penlon | Sigma Delta MRI | FDA UDI | Class II | Unknown |
| Penlon | 4840-113 | FDA UDI | Class II | Active |
| SC760 MRI Suction Controller 4m hose | SC760 MRI | FDA UDI | Class II | Active |
| Penlon | 408001005 | FDA UDI | Class I | Active |
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