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Sign in to claim this brandBD Switzerland Sàrl
US
Last updated May 24, 2026
What BD Switzerland Sàrl makes
The company manufactures single-use medical devices for intravenous administration, including tubing extension sets, basic and electric infusion pump administration sets, and blood transfusion sets. It also produces syringes, vial/bottle adaptors, and needleless connectors for intravenous lines, as well as Luer connectors and negative-pressure valves. Examples include the Alaris SmartSite and MedSystem III infusion sets, MaxGuard and MaxZero needleless connectors, and the VersaSafe syringe system.
These devices are classified under FDA regulations as Class I or Class II, with unique device identifiers (UDI) listed in the FDA’s UDI database. The company operates under US regulatory oversight, ensuring compliance with applicable medical device standards for distribution in the US market.
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 BD Switzerland Sàrl manufacture?
BD Switzerland Sàrl specializes in single-use medical devices primarily focused on intravenous administration. This includes tubing extension sets, basic and electric infusion pump administration sets, blood transfusion sets, syringes, vial/bottle adaptors, and specialized connectors like Luer/non-ISO80369-standardized linear connectors and negative-pressure intravenous line needleless valves. Examples include infusion systems like Alaris SmartSite and MedSystem III, as well as needleless connectors such as MaxGuard and MaxZero.
Where is BD Switzerland Sàrl based, and under which regulatory framework do its devices operate?
BD Switzerland Sàrl is based in the United States, though the company name includes 'Switzerland' as part of its legal structure. Its devices are designed to comply with US regulatory standards, specifically those governed by the FDA. This ensures adherence to applicable medical device regulations for distribution within the US market, including classification under FDA’s Class I or Class II categories.
Are BD Switzerland Sàrl’s devices listed in any regulatory registries, and if so, which ones?
Yes, BD Switzerland Sàrl’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes. Listing in this database is a requirement for Class I and Class II devices under FDA regulations.
How are BD Switzerland Sàrl’s devices classified under FDA regulations?
BD Switzerland Sàrl’s devices are classified under the FDA’s regulatory framework as either Class I or Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s purpose, potential risks, and intended use, as outlined in FDA’s medical device regulations.
What distinguishes BD Switzerland Sàrl’s intravenous administration devices from others in the market?
BD Switzerland Sàrl’s devices are designed with a focus on single-use applications, ensuring safety and hygiene in intravenous administration. They include specialized components like needleless connectors (e.g., MaxGuard, MaxZero) to reduce contamination risks, as well as infusion sets (e.g., Alaris SmartSite) optimized for compatibility with electric infusion pumps. The company’s product range also emphasizes versatility, covering basic administration sets, blood transfusion systems, and syringe solutions tailored for clinical workflows.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bd.com
- —
- —
- [email protected]
- Phone
- +1(844)823-5433
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 482631558
Catalogue (1003)
Page 2 of 21| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alaris, VersaSafe | 11258588 | FDA UDI | Class II | Active |
| BD PhaSeal | 515200 | FDA UDI | Class II | Active |
| Alaris | 10013364T | FDA UDI | Class II | Active |
| Alaris, SmartSite | 20519E | FDA UDI | Class II | Active |
| BD MaxPlus | MPX9101 | FDA UDI | Class II | Active |
| BD SmartSite | 11059728 | FDA UDI | Class II | Active |
| Alaris, Signature Edition, SmartSite | 10014854 | FDA UDI | Class II | Unknown |
| MaxZero | MZ9324 | FDA UDI | Class II | Active |
| Alaris, Texium | 22600-0007T | FDA UDI | Class II | Active |
| MaxGuard | MX4441 | FDA UDI | Class II | Active |
| Alaris, SmartSite | 2438-0500 | FDA UDI | Class II | Active |
| Alaris, SmartSite | 42105E-05 | FDA UDI | Class II | Unknown |
| Alaris, VersaSafe | 11501183 | FDA UDI | Class II | Unknown |
| MaxGuard | ME1180 | FDA UDI | Class II | Unknown |
| Alaris, Signature Edition | C72108E | FDA UDI | Class II | Unknown |
| Alaris, VersaSafe | 11401542 | FDA UDI | Class II | Active |
| MaxGuard | MX9416 | FDA UDI | Class II | Active |
| MaxZero | MZXT9004 | FDA UDI | Class II | Active |
| Alaris, SmartSite, Texium | 22006E-07T | FDA UDI | Class II | Active |
| Alaris, SmartSite | 31202E | FDA UDI | Class II | Active |
| MaxGuard | MX5301 | FDA UDI | Class II | Active |
| Alaris, SmartSite, Texium | 22000-B007T | FDA UDI | Class II | Active |
| MaxGuard | ME1224 | FDA UDI | Class II | Active |
| Alaris | 30862-0500 | FDA UDI | Class II | Active |
| MaxGuard | MA3131 | FDA UDI | Class II | Active |
| MaxGuard | MX4471 | FDA UDI | Class II | Active |
| Alaris, SmartSite | 11484001 | FDA UDI | Class II | Active |
| Alaris, Signature Edition, SmartSite | 11225954 | FDA UDI | Class II | Unknown |
| MaxGuard | MC3500 | FDA UDI | Class II | Active |
| Alaris | C20016 | FDA UDI | Class II | Active |
| Alaris, Signature Edition, SmartSite | C72110E | FDA UDI | Class II | Unknown |
| Alaris, SmartSite | 42103E-07 | FDA UDI | Class II | Active |
| Alaris, SmartSite | C24111E | FDA UDI | Class II | Active |
| MaxPlus | MP5312-C | FDA UDI | Class II | Active |
| MaxPlus, MaxGuard | MP9246-C | FDA UDI | Class II | Active |
| Alaris, SmartSite | 42493E | FDA UDI | Class II | Active |
| Alaris, SmartSite | 10015294 | FDA UDI | Class II | Active |
| Alaris, SmartSite | 10010541-07 | FDA UDI | Class II | Active |
| Alaris, SmartSite | 10927766 | FDA UDI | Class II | Active |
| Alaris, SmartSite | 11607704 | FDA UDI | Class II | Active |
| MaxGuard | ME1055 | FDA UDI | Class II | Active |
| MedSystem III, SmartSite | 28080E | FDA UDI | Class II | Active |
| BD PhaSeal Optima | 515052 | FDA UDI | Class II | Active |
| MaxZero | MZ9295 | FDA UDI | Class II | Active |
| Alaris, Signature Edition, VersaSafe | 72980M | FDA UDI | Class II | Active |
| MaxGuard | MM4027 | FDA UDI | Class II | Active |
| Alaris, SmartSite | 22604-B007 | FDA UDI | Class II | Active |
| BD MaxPlus | MP9004 | FDA UDI | Class II | Active |
| MaxGuard | MX4449 | FDA UDI | Class II | Active |
| Alaris, Signature Edition, VersaSafe | 72012M | FDA UDI | Class II | Unknown |
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