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 10 of 11

Device	Model / Reference	Registries	Class	Status
Tyshak	PDC004	EUDAMED	Class III	Active
Z-Med	PDZ310	EUDAMED	Class III	Active
NuCLEUS-X	PVN406	EUDAMED	Class III	Active
Z-Med Ii	PDZ679	EUDAMED	Class III	Active
Tyshak II	SN004	EUDAMED	Class III	Active
Z-Med-X	PDZ417	EUDAMED	Class III	Active
Tyshak	PDC038	EUDAMED	Class III	Active
Tyshak	PDC152	EUDAMED	Class III	Active
Tyshak	PDC144	EUDAMED	Class III	Active
Tyshak II	SO036	EUDAMED	Class III	Active
NuCLEUS-X	PVN400	EUDAMED	Class III	Active
Z-Med Ii-X	PDZ751	EUDAMED	Class III	Active
Z-Med-X	PDZ413	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN019	EUDAMED	Class III	Active
Mullins-X	PTM446	EUDAMED	Class III	Active
Tyshak	PDC065	EUDAMED	Class III	Active
Tyshak	PDC201	EUDAMED	Class III	Active
Tyshak	PDC173	EUDAMED	Class III	Active
Z-Med	PDZ346	EUDAMED	Class III	Active
Tyshak II	PDC549	EUDAMED	Class III	Active
Z-Med	PDZ387	EUDAMED	Class III	Active
Tyshak	PDC151	EUDAMED	Class III	Active
Tyshak	PDC098	EUDAMED	Class III	Active
Z-Med	SO050	EUDAMED	Class III	Active
Tyshak II	SO018	EUDAMED	Class III	Active
Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)	P150028	FDA PMA	Class III	Active
Z-Med	SO064	EUDAMED	Class III	Active
Tyshak	PDC046	EUDAMED	Class III	Active
Tyshak II	SN11290	EUDAMED	Class III	Active
Tyshak-X	PDC305	EUDAMED	Class III	Active
Mounted CP Stent (MCP028 / 426)	MCP028	EUDAMED	Class III	Active
Tyshak	PDC090	EUDAMED	Class III	Active
Z-Med Ii-X	PDZ745	EUDAMED	Class III	Active
Covered Mounted CP Stent	CMCP017	EUDAMED	Class III	Active
Covered Mounted CP Stent	CMCP010	EUDAMED	Class III	Active
COEfficient	COE102	EUDAMED	Class III	Active
Mounted CP Stent	MCP022	EUDAMED	Class III	Active
Tyshak	PDC032	EUDAMED	Class III	Active
COEfficient	COE146	EUDAMED	Class III	Active
Tyshak Mini	SO097	EUDAMED	Class III	Active
Z-Med Ii	PDZ611	EUDAMEDFDA 510(k)	Class III	Active
Bib	BB070	EUDAMED	Class III	Active
Z-Med	PDZ383	EUDAMED	Class III	Active
CP Stent	CP8Z22	EUDAMED	Class III	Active
Tyshak	PDC104	EUDAMED	Class III	Active
Tyshak	PDC099	EUDAMED	Class III	Active
Z-Med Ii	PDZ675	EUDAMED	Class III	Active
Covered CP Stent	CVRDCP10Z45	EUDAMED	Class III	Active
COEfficient	COE138	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN016	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.