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Sign in to claim this brandMozarc Medical US LLC
US
Last updated September 17, 2026
About
Mozarc Medical focuses exclusively on developing meaningful and innovative kidney health technologies globally that reimagine holistic kidney care for the future – including kidney access solutions, home dialysis technologies, and advancements in acute therapies. Because patients, caregivers, clinicians -- they all deserve better. We are here. We are ready. We are Mozarc Medical. Learn more by visiting mozarcmedical.com.
From the manufacturer's own website. Source
What Mozarc Medical US LLC makes
Mozarc Medical US LLC manufactures haemodialysis and peritoneal dialysis catheters, including single-use and implantable double-lumen and triple-lumen designs for vascular access. Their portfolio also includes hollow-fibre haemodialysis dialysers, catheter introduction sets for vascular and peritoneal procedures, and basic peripheral angioplasty balloon catheters.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Mozarc Medical US LLC is based 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 Mozarc Medical US LLC manufacture?
Mozarc Medical US LLC specializes in devices primarily used for kidney health care. Their portfolio includes haemodialysis and peritoneal dialysis catheters, such as double-lumen and triple-lumen catheters (both nonimplantable and implantable), as well as hollow-fibre haemodialysis dialysers designed for single-use. They also produce catheter introduction sets for vascular and peritoneal procedures and basic peripheral angioplasty balloon catheters. These devices are engineered to support vascular access and dialysis therapies.
Where is Mozarc Medical US LLC based?
Mozarc Medical US LLC is headquartered in the United States. The company’s focus on kidney health technologies and global innovation is centered from this location, though its products are intended for use worldwide.
Which regulatory registries or databases list Mozarc Medical US LLC’s devices?
Mozarc Medical US LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers and regulators, helping to identify and track specific devices by their unique identifiers.
How are Mozarc Medical US LLC’s devices classified by regulatory authorities?
Mozarc Medical US LLC’s devices fall under two categories of FDA classification: Class I and Class II. Class I devices generally pose the lowest 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 intended use, potential risks, and the body part it interacts with, such as vascular access or dialysis procedures.
What distinguishes Mozarc Medical US LLC’s device portfolio from others in the kidney health space?
Mozarc Medical US LLC’s portfolio is defined by its focus on kidney access solutions and dialysis technologies, including both haemodialysis and peritoneal dialysis systems. Their offerings span a range of devices—from catheters and dialysers to introduction sets and angioplasty balloons—designed to improve vascular access and support acute or chronic dialysis therapies. This breadth allows them to address multiple stages of patient care, from initial access to ongoing treatment, with an emphasis on innovation and patient-centric design.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 15 Hampshire Street, Mansfield, MA, 02048
- Website
- mozarcmedical.com/
- linkedin.com/company/mozarcmedical
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- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3030574705
- DUNS Number
- —
Catalogue (695)
Page 5 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MAHURKAR Elite | 8888222424 | FDA UDI | Class II | Active |
| Palindrome | 8888145040P | FDA UDI | Class II | Active |
| Mahurkar | 8888345611 | FDA UDI | Class II | Active |
| Argyle | 8813796001 | FDA UDI | Class II | Active |
| Palindrome | 8888119371P | FDA UDI | Class II | Active |
| Palindrome | 8888133511P | FDA UDI | Class II | Active |
| Argyle | 8888415679 | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888211416 | FDA UDI | Class II | Active |
| Palindrome | 8888541119 | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888221430 | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888231230 | FDA UDI | Class II | Active |
| Mahurkar | 8888345603HP | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888211124 | FDA UDI | Class II | Active |
| Mahurkar | 8813793009 | FDA UDI | Class II | Active |
| Argyle | 8817278007 | FDA UDI | Class II | Active |
| Palindrome | 8888145042P | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888222213 | FDA UDI | Class II | Active |
| Mahurkar | 8888135198 | FDA UDI | Class II | Active |
| Palindrome | 8888541023P | FDA UDI | Class II | Unknown |
| Palindrome | 8888145049CP | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888213213 | FDA UDI | Class II | Active |
| Mahurkar | 8888135192 | FDA UDI | Class II | Active |
| Palindrome | 8888145044P | FDA UDI | Class II | Active |
| Palindrome | 8888145065 | FDA UDI | Class II | Active |
| Palindrome | 8888145041 | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888231424 | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888231116 | FDA UDI | Class II | Active |
| Argyle | 8888422501 | FDA UDI | Class II | Unknown |
| Mahurkar | 8888115132 | FDA UDI | Class II | Unknown |
| Palindrome | 8888128450 | FDA UDI | Class II | Active |
| Argyle | 8810890014 | FDA UDI | Class II | Active |
| Mahurkar | 8888135131 | FDA UDI | Class II | Active |
| Mahurkar | 8813816009 | FDA UDI | Class II | Active |
| Mahurkar | 8831662001 | FDA UDI | Class II | Active |
| Tandem-Cath | 8888223266 | FDA UDI | Class II | Unknown |
| MAHURKAR Elite | 8888222320 | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888231224 | FDA UDI | Class II | Active |
| Mahurkar | 8888102003HP | FDA UDI | Class II | Active |
| Palindrome | 8888123411 | FDA UDI | Class II | Unknown |
| Mahurkar | 8888345629HP | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888221124 | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888211413 | FDA UDI | Class II | Active |
| Mahurkar | 8888345512 | FDA UDI | Class II | Unknown |
| Mahurkar | 8831173010 | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888212213 | FDA UDI | Class II | Active |
| MAHURKAR Elite | 8888231420 | FDA UDI | Class II | Active |
| Argyle | 8888422105 | FDA UDI | Class II | Unknown |
| Mahurkar | 8888135246 | FDA UDI | Class II | Unknown |
| MAHURKAR Elite | 8888223413 | FDA UDI | Class II | Active |
| Palindrome | 8888123408 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
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Authorities
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FDA Recalls (12)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Mozarc Medical US LLC has initiated 12 recall records between April 23, 2025, and April 29, 2026. The records include both open and classified statuses. Reasons cited involve missing components in product labeling for the Mahurkar Elite PASS Trays, potential seal integrity issues with header bag packaging, and potential breaches of sterile barrier packaging.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 29, 2026 | Z-2319-2026 | — | open, classified | The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. |
| Oct 17, 2025 | Z-0424-2026 | — | open, classified | A potential issue with the seal integrity of header bag packaging. |
| Oct 17, 2025 | Z-0425-2026 | — | open, classified | A potential issue with the seal integrity of header bag packaging. |
| Oct 17, 2025 | Z-0423-2026 | — | open, classified | A potential issue with the seal integrity of header bag packaging. |
| Oct 17, 2025 | Z-0422-2026 | — | open, classified | A potential issue with the seal integrity of header bag packaging. |
| Oct 17, 2025 | Z-0421-2026 | — | open, classified | A potential issue with the seal integrity of header bag packaging. |
| Oct 17, 2025 | Z-0426-2026 | — | open, classified | A potential issue with the seal integrity of header bag packaging. |
| Apr 23, 2025 | Z-1888-2025 | — | open, classified | Potential breach of sterile barrier packaging. |
| Apr 23, 2025 | Z-1887-2025 | — | open, classified | Potential breach of sterile barrier packaging. |
| Apr 23, 2025 | Z-1886-2025 | — | open, classified | Potential breach of sterile barrier packaging. |
| Apr 23, 2025 | Z-1889-2025 | — | open, classified | Potential breach of sterile barrier packaging. |
| Apr 23, 2025 | Z-1885-2025 | — | open, classified | Potential breach of sterile barrier packaging. |