Is this your brand? Sign in to claim ownership.

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 6 of 11

Device	Model / Reference	Registries	Class	Status
Z-Med	PDZ362	EUDAMED	Class III	Active
Z-MEd	PDZ368	EUDAMED	Class III	Active
Z-Med	PDZ380	EUDAMED	Class III	Active
Z-Med	SO026	EUDAMED	Class III	Active
Z-Med-X	PDZ405	EUDAMED	Class III	Active
Tyshak II	SN002	EUDAMED	Class III	Active
Bib	BB065	EUDAMED	Class III	Active
Tyshak	PDC165	EUDAMED	Class III	Active
COEfficient	COE109	EUDAMED	Class III	Active
Tyshak	PDC036	EUDAMED	Class III	Active
Tyshak II	SN005	EUDAMED	Class III	Active
Z-Med Ii-X	PDZ723	EUDAMED	Class III	Active
Z-Med Ii	PDZ684	EUDAMED	Class III	Active
Tyshak II	PDC532	EUDAMED	Class III	Active
Z-Med	SO059	EUDAMED	Class III	Active
Z-Med	PDZ393	EUDAMED	Class III	Active
Bib	BB072	EUDAMED	Class III	Active
Z-Med	PDZ334	EUDAMED	Class III	Active
Tyshak	PDC016	EUDAMED	Class III	Active
Z-Med Ii	PDZ653	EUDAMED	Class III	Active
Tyshak	PDC034	EUDAMED	Class III	Active
COEfficient	COE114	EUDAMED	Class III	Active
Z-Med	SO056	EUDAMED	Class III	Active
Bib	BB064	EUDAMED	Class III	Active
Bib	BB018	EUDAMED	Class III	Active
Z-Med Ii-X	PDZ716	EUDAMED	Class III	Active
Tyshak II	PDC521	EUDAMED	Class III	Active
Z-Med-X	PDZ438	EUDAMED	Class III	Active
Z-Med	SO092	EUDAMED	Class III	Active
Z-Med-X	PDZ403	EUDAMED	Class III	Active
Tyshak	PDC048	EUDAMED	Class III	Active
Tyshak-X	PDC343	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN001	EUDAMED	Class III	Active
Tyshak Mini	SO098	EUDAMED	Class III	Active
Tyshak	PDC128	EUDAMED	Class III	Active
Tyshak II	PDC551	EUDAMED	Class III	Active
Tyshak	PDC049	EUDAMED	Class III	Active
Z-Med	PDZ315	EUDAMED	Class III	Active
Tyshak-X	PDC330	EUDAMED	Class III	Active
Z-Med	SN026	EUDAMED	Class III	Active
Tyshak	PDC033	EUDAMED	Class III	Active
Z-Med Ii	PDZ637	EUDAMED	Class III	Active
Z-Med Ii	SN045	EUDAMED	Class III	Active
Tyshak	PDC072	EUDAMED	Class III	Active
Z-Med	PDZ382	EUDAMED	Class III	Active
Tyshak	PDC121	EUDAMED	Class III	Active
NuCLEUS-X	PVN412	EUDAMED	Class III	Active
Tyshak-X	PDC307	EUDAMED	Class III	Active
Z-Med	PDZ328	EUDAMED	Class III	Active
NuCLEUS-X	PVN414	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.