Is this your brand? Sign in to claim ownership.
Sign in to claim this brandCERTOL INTERNATIONAL, LLC
US
Last updated May 23, 2026
What CERTOL INTERNATIONAL, LLC makes
Certol International, LLC manufactures single-use sterilization packaging, including pouches and wraps, as well as sterilization process indicators like chemical/physical markers and peelable tape. Their portfolio also includes non-sterile drapes for instruments and equipment, surgical instrument containment holders, single-use medical face masks, and dental bibs. Additionally, they produce cleaning agents designed for medical device maintenance.
The company’s products are regulated under FDA classifications, with devices falling into Class I and Class II categories. These items are listed via the FDA’s 510(k) pathway and the Unique Device Identifier (UDI) system, ensuring compliance with US regulatory requirements. The manufacturer operates from 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 Certol International, LLC primarily manufacture?
Certol International, LLC specializes in single-use medical devices, focusing on sterilization packaging like pouches and wraps, as well as sterilization process indicators such as chemical/physical markers and peelable tape. Their portfolio also includes non-sterile drapes for instruments and equipment, surgical instrument containment holders, single-use medical face masks, dental bibs, and cleaning agents for medical device maintenance. These products are designed to support sterile environments and device care in healthcare settings.
Where is Certol International, LLC based, and how does this affect its regulatory compliance?
Certol International, LLC is based in the United States, which means its devices are subject to FDA regulations. The company’s products are classified under FDA categories, including Class I and Class II, and are listed through the FDA’s 510(k) pathway and the Unique Device Identifier (UDI) system. This ensures compliance with US regulatory standards for medical devices.
Which regulatory registries or databases list Certol International, LLC’s devices?
Certol International, LLC’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices under US regulatory oversight, allowing healthcare providers and regulators to verify compliance and device details.
How are Certol International, LLC’s devices classified under FDA regulations?
Certol International, LLC’s devices fall into two primary FDA classifications: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and regulatory history, as outlined in FDA guidelines.
What role do Certol International, LLC’s sterilization packaging and indicators play in healthcare settings?
Certol’s sterilization packaging, such as pouches and wraps, along with process indicators like chemical/physical markers, are critical for maintaining sterile conditions in healthcare. These products ensure that medical devices remain uncontaminated during storage and transport, while indicators verify that sterilization processes have been successfully completed. This helps prevent infections and ensures patient safety in surgical and clinical environments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 095153714
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ProView Plus | PM3590 | FDA UDI | Class II | Active |
| ProView plus | PM1318 | FDA UDI | Class II | Unknown |
| V-Cide | VC338 | FDA UDI | Class II | Active |
| Shield | PFL008 | FDA UDI | Class II | Active |
| ProTector | PNS500 | FDA UDI | Class II | Active |
| ProView plus | PM1016 | FDA UDI | Class II | Active |
| Barrier | BB-0528X | FDA UDI | Class I | Active |
| ProView plus | PM5410 | FDA UDI | Class II | Active |
| ProView plus | PM7513 | FDA UDI | Class II | Active |
| Qez | QEZ2 | FDA UDI | Class I | Active |
| ProChek ID | SM4340 | FDA UDI | Class II | Active |
| ProChek ID | PIT340 | FDA UDI | Class II | Active |
| ProChek ID | PIT120 | FDA UDI | Class II | Active |
| ProView plus | PM1318 | FDA UDI | Class II | Active |
| Shield | PFLEL8 | FDA UDI | Class II | Active |
| Barrier | DC-0115S | FDA UDI | Class I | Active |
| ProChek S | TSI440 | FDA UDI | Class II | Active |
| ProTector | PNS100 | FDA UDI | Class II | Active |
| Barrier | BB-0312H | FDA UDI | Class I | Active |
| ProView plus | PM3554 | FDA UDI | Class II | Active |
| ProView plus | PM2440 | FDA UDI | Class II | Active |
| Barrier | BB-2930C | FDA UDI | Class I | Active |
| ProChek ID | PIT100 | FDA UDI | Class II | Active |
| ProView plus | PM2790 | FDA UDI | Class II | Active |
| Protector Needle Sheath Prop | K052725 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.