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Mozarc Medical US LLC

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

Information

Country: US
Address: 15 Hampshire Street, Mansfield, MA, 02048
Website: mozarcmedical.com/
LinkedIn: linkedin.com/company/mozarcmedical
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3030574705
DUNS Number: —

Catalogue (695)

Page 1 of 14

Device	Model / Reference	Registries	Class	Status
Mahurkar	8888135248	FDA UDI	Class II	Active
Argyle	8888411405	FDA UDI	Class II	Active
Mahurkar	8888104003HP	FDA UDI	Class II	Active
Palindrome	8888145040	FDA UDI	Class II	Active
Mahurkar	8833074003	FDA UDI	Class II	Active
Palindrome	8888119371	FDA UDI	Class II	Active
Palindrome	8888145063CP	FDA UDI	Class II	Unknown
Mahurkar	8888102003	FDA UDI	Class II	Unknown
Palindrome	8888145046CP	FDA UDI	Class II	Active
Mahurkar	8831663001	FDA UDI	Class II	Active
Mahurkar	8888345538HP	FDA UDI	Class II	Active
Mahurkar	8888135138	FDA UDI	Class II	Active
Palindrome	8888145066CP	FDA UDI	Class II	Active
Palindrome	8888123404	FDA UDI	Class II	Active
Mahurkar	8817277027	FDA UDI	Class II	Active
Clearum Hs	IBP4373	FDA UDI	Class II	Active
Palindrome	8888145064P	FDA UDI	Class II	Active
Mahurkar	8888135139	FDA UDI	Class II	Unknown
Palindrome	8888145068P	FDA UDI	Class II	Active
Mahurkar	8888102004HP	FDA UDI	Class II	Unknown
Mahurkar	8888130556	FDA UDI	Class II	Active
Palindrome	8888123405P	FDA UDI	Class II	Active
MAHURKAR Elite	8888212324	FDA UDI	Class II	Active
Mahurkar	8888133535	FDA UDI	Class II	Active
MAHURKAR Elite	8888211116	FDA UDI	Class II	Unknown
Mahurkar	8888340629HP	FDA UDI	Class II	Active
Palindrome	8888145043C	FDA UDI	Class II	Active
MAHURKAR Elite	8888233413	FDA UDI	Class II	Active
Argyle	8888422378	FDA UDI	Class II	Unknown
MAHURKAR Elite	8888211420	FDA UDI	Class II	Active
Mahurkar	8888101003HP	FDA UDI	Class II	Unknown
Palindrome	8888145050P	FDA UDI	Class II	Active
Argyle	8888422295	FDA UDI	Class II	Unknown
Mahurkar	8888135138	FDA UDI	Class II	Active
Mahurkar	8831661001	FDA UDI	Class II	Active
Palindrome	8888145057C	FDA UDI	Class II	Active
Mahurkar	8888135161	FDA UDI	Class II	Active
MAHURKAR Elite	8888222113	FDA UDI	Class II	Active
MAHURKAR Elite	8888233224	FDA UDI	Class II	Active
Palindrome	8888145044CP	FDA UDI	Class II	Active
MAHURKAR Elite	8888233220	FDA UDI	Class II	Active
MAHURKAR Elite	8888211216	FDA UDI	Class II	Active
Ritus	8888413815	FDA UDI	Class II	Active
Mahurkar	8888345637	FDA UDI	Class II	Active
MAHURKAR Elite	8888233420	FDA UDI	Class II	Active
Ritus	8888412015	FDA UDI	Class II	Active
MAHURKAR Elite	8888223420	FDA UDI	Class II	Active
Mahurkar	8888102003HP	FDA UDI	Class II	Active
Argyle	8888425728	FDA UDI	Class II	Active
MAHURKAR Elite	8888213416	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.

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.