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NuMED, Inc.

United States·US-MF-000010948

Last updated September 17, 2026

Information

Country: United States
Address: 2880, Main Street, Hopkinton, United States
Website: numedusa.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-315-328-4491
PRRC Contact: Nichelle LaFlesh
EUDAMED SRN: US-MF-000010948
FDA FEI Number: 1318694
DUNS Number: 114186877

Catalogue (511)

Page 4 of 11

Device	Model / Reference	Registries	Class	Status
Z-Med Ii-X	PDZ749	EUDAMED	Class III	Active
COEfficient	COE145	EUDAMED	Class III	Active
Tyshak-X	PDC340	EUDAMED	Class III	Active
Z-Med	PDZ335	EUDAMED	Class III	Active
NuCLEUS-X	PVN405	EUDAMED	Class III	Active
Tyshak-X	PDC334	EUDAMED	Class III	Active
Z-Med	SO051	EUDAMED	Class III	Active
Tyshak-X	PDC329	EUDAMED	Class III	Active
COEfficient	COE127	EUDAMED	Class III	Active
Tyshak	PDC103	EUDAMED	Class III	Active
Z-Med Ii	PDZ671	EUDAMED	Class III	Active
Tyshak	PDC069	EUDAMED	Class III	Active
Z-Med	SO085	EUDAMED	Class III	Active
Tyshak	PDC182	EUDAMED	Class III	Active
Z-Med	SO083	EUDAMED	Class III	Active
COEfficient	COE113	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN015	EUDAMED	Class III	Active
Tyshak	PDC057	EUDAMED	Class III	Active
Bib	BB057	EUDAMED	Class III	Active
Tyshak	PDC093	EUDAMED	Class III	Active
Bib	BB042	EUDAMED	Class III	Active
Z-Med Ii	PDZ601	EUDAMED	Class III	Active
Tyshak	PDC189	EUDAMED	Class III	Active
Z-Med Ii	PDZ608	EUDAMED	Class III	Active
Tyshak	PDC119	EUDAMED	Class III	Active
Z-Med Ii	PDZ621	EUDAMED	Class III	Active
Tyshak II	SO003	EUDAMED	Class III	Active
Mullins-X	PTM452	EUDAMED	Class III	Active
Z-Med Ii	SO040	EUDAMED	Class III	Active
Z-Med-X	PDZ432	EUDAMED	Class III	Active
Tyshak	PDC179	EUDAMED	Class III	Active
Mullins-X	PTM448	EUDAMED	Class III	Active
COEfficient	COE134	EUDAMED	Class III	Active
Z-Med	SO080	EUDAMED	Class III	Active
Tyshak	PDC068	EUDAMED	Class III	Active
Z-Med	PDZ339	EUDAMED	Class III	Active
Tyshak	PDC202	EUDAMED	Class III	Active
Tyshak	PDC044	EUDAMED	Class III	Active
Tyshak	PDC012	EUDAMED	Class III	Active
Z-Med-X	PDZ420	EUDAMED	Class III	Active
Z-Med Ii	PDZ639	EUDAMED	Class III	Active
Bib	BB039	EUDAMED	Class III	Active
Tyshak	PDC200	EUDAMED	Class III	Active
Bib	BB075	EUDAMED	Class III	Active
Tyshak	PDC116	EUDAMED	Class III	Active
Z-Med-X	PDZ448	EUDAMED	Class III	Active
Z-Med	PDZ309	EUDAMED	Class III	Active
Z-Med-X	PDZ409	EUDAMED	Class III	Active
Tyshak II	PDC535	EUDAMED	Class III	Active
Tyshak	PDC095	EUDAMED	Class III	Active

Related Companies

Authorised Representatives

G. van Wageningen B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (5)

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 21, 2025	Z-1754-2025	—	terminated	Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
Oct 17, 2018	Z-0510-2019	—	terminated	Instructions for Use booklets were not included on the outer pouch
Oct 17, 2018	Z-0511-2019	—	terminated	Instructions for Use booklets were not included on the outer pouch
Sep 23, 2009	Z-0509-2010	—	terminated	The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The product was still in its packaging and never used. The customer referred to it as looking like "paint crackle." The risk is that for continued sterility to be assured, the packaging must remain intact.
Jun 26, 2003	Z-0983-03	—	terminated	Lacks a PMA or 510k.