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Sign in to claim this brandConcordance Healthcare Solutions LLC
US
Last updated May 23, 2026
What Concordance Healthcare Solutions LLC makes
Concordance Healthcare Solutions LLC manufactures basic clinical and examination tools, including manual blood pressure monitors like aneroid sphygmomanometers and reusable blood pressure cuffs, as well as single-use items such as non-antimicrobial gauze pads, swabs, and underpads. Their portfolio also includes examination gloves, stethoscopes, and surgical or examination garment kits designed for general medical and procedural use.
The company’s devices are classified under FDA’s Class I and Class II categories, with some falling under the exemptions for Class U. These products are listed in the FDA’s Unique Device Identifier (UDI) database, adhering to regulatory requirements for medical devices in 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 Concordance Healthcare Solutions LLC manufacture?
Concordance Healthcare Solutions LLC produces a range of basic clinical and examination tools. These include manual blood pressure measurement devices like aneroid sphygmomanometers and reusable blood pressure cuffs, as well as single-use items such as non-antimicrobial gauze pads, swabs, and underpads. Their portfolio also covers examination gloves, mechanical stethoscopes, and surgical or examination garment kits, all designed for general medical and procedural use.
Where is Concordance Healthcare Solutions LLC based?
Concordance Healthcare Solutions LLC is based in the United States. The company’s devices are developed and manufactured within this regulatory framework, ensuring compliance with U.S. medical device standards.
Which regulatory registries or databases list Concordance Healthcare Solutions LLC’s devices?
Concordance Healthcare Solutions LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is a key resource for tracking and identifying medical devices authorized for use in the United States, ensuring transparency and traceability.
How are Concordance Healthcare Solutions LLC’s devices classified under FDA regulations?
Concordance Healthcare Solutions LLC’s devices fall under FDA’s Class I and Class II categories, which determine the level of regulatory oversight required. Some of their products are also classified under Class U exemptions, meaning they are subject to fewer regulatory controls due to their low-risk nature. Classification depends on factors like intended use, potential risks, and design complexity.
Why are some of Concordance Healthcare Solutions LLC’s devices listed in the FDA’s UDI database?
The FDA’s Unique Device Identifier (UDI) database includes devices that are authorized for sale in the U.S. to ensure traceability, reduce medical errors, and improve patient safety. Since Concordance Healthcare Solutions LLC’s products are manufactured and marketed in the U.S., they must comply with UDI requirements to maintain regulatory compliance and transparency in the healthcare system.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 080220245
Catalogue (224)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hcs | HCS8006 | FDA UDI | Class I | Active |
| Hcs | HCS1108 | FDA UDI | Class I | Active |
| Hcs | HCS7701B-2XR | FDA UDI | Class I | Active |
| Hcs | HCS9005LF | FDA UDI | Class II | Active |
| Hcs | 94412 | FDA UDI | Class I | Active |
| Hcs | HCS0211 | FDA UDI | Class I | Active |
| Hcs | HCS1002 | FDA UDI | Class I | Active |
| Hcs | 93448-2 | FDA UDI | Class I | Active |
| Hcs | 9027LF | FDA UDI | Class II | Active |
| Hcs | HCS3012 | FDA UDI | Class I | Active |
| Hcs | 932212NS | FDA UDI | Class I | Active |
| Hcs | 1122S | FDA UDI | Class I | Active |
| Hcs | HCS1007P | FDA UDI | Class I | Active |
| Hcs | 92212-1 | FDA UDI | Class I | Active |
| Hcs | HCS1004 | FDA UDI | Class I | Active |
| HCS Sourcing | 710008QR | FDA UDI | Class II | Active |
| Hcs | 94480-2 | FDA UDI | Class I | Active |
| Hcs | 9026LF | FDA UDI | Class II | Active |
| Hcs | HCS9028LF | FDA UDI | Class II | Active |
| Hcs | HCS6622 | FDA UDI | Class I | Active |
| HCS Sourcing | 710005R | FDA UDI | Class II | Active |
| Hcs | HCS8004 | FDA UDI | Class I | Active |
| Hcs | HCS8007 | FDA UDI | Class I | Active |
| Hcs | HCS3014 | FDA UDI | Class II | Active |
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