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 9 of 11

Device	Model / Reference	Registries	Class	Status
Z-Med Ii	SN017	EUDAMED	Class III	Active
Tyshak	PDC007	EUDAMED	Class III	Active
Tyshak II	PDC503	EUDAMED	Class III	Active
Z-Med	PDZ396	EUDAMED	Class III	Active
Z-Med	PDZ316	EUDAMED	Class III	Active
Z-Med Ii	SN038	EUDAMED	Class III	Active
Bib	BB058	EUDAMED	Class III	Active
Tyshak	PDC086	EUDAMED	Class III	Active
Z-Med Ii	SN037	EUDAMED	Class III	Active
Tyshak	PDC081	EUDAMED	Class III	Active
Tyshak-X	PDC347	EUDAMED	Class III	Active
Z-Med Ii	PDZ670	EUDAMED	Class III	Active
NuCLEUS-X	PVN410	EUDAMED	Class III	Active
Z-Med Ii-X	PDZ733	EUDAMED	Class III	Active
Tyshak	SO015	EUDAMED	Class III	Active
Tyshak	PDC018	EUDAMED	Class III	Active
Z-Med-X	PDZ402	EUDAMED	Class III	Active
Bib	BB073	EUDAMED	Class III	Active
Bib	BB020	EUDAMED	Class III	Active
Tyshak	PDC075	EUDAMED	Class III	Active
COEfficient	COE150	EUDAMED	Class III	Active
Z-Med Ii	PDZ636	EUDAMED	Class III	Active
Z-Med	PDZ364	EUDAMED	Class III	Active
Tyshak II	PDC546	EUDAMED	Class III	Active
Bib	BB019	EUDAMED	Class III	Active
Tyshak II	PDC507	EUDAMED	Class III	Active
NuCLEUS-X	PVN415	EUDAMED	Class III	Active
Bib	BB062	EUDAMED	Class III	Active
Mullins-X	PTM449	EUDAMED	Class III	Active
Tyshak II	SO035	EUDAMED	Class III	Active
Tyshak-X	PDC331	EUDAMED	Class III	Active
Tyshak	PDC125	EUDAMED	Class III	Active
COEfficient	COE119	EUDAMED	Class III	Active
Z-Med Ii	SN019	EUDAMED	Class III	Active
Z-Med Ii-X	PDZ740	EUDAMED	Class III	Active
Z-Med Ii	PDZ664	EUDAMED	Class III	Active
Z-Med Ii	PDZ603	EUDAMED	Class III	Active
Z-Med-X	PDZ422	EUDAMED	Class III	Active
Z-Med-X	PDZ406	EUDAMED	Class III	Active
Z-Med Ii	PDZ615	EUDAMED	Class III	Active
Z-Med Ii	SO068	EUDAMED	Class III	Active
Tyshak Mini	SO095	EUDAMED	Class III	Active
Tyshak-X	PDC337	EUDAMED	Class III	Active
Tyshak-X	PDC322	EUDAMED	Class III	Active
Z-Med	SO088	EUDAMED	Class III	Active
Tyshak Mini	SO104	EUDAMED	Class III	Active
Tyshak Mini	PDC409	EUDAMEDFDA 510(k)	Class III	Active
Z-Med Ii	PDZ659	EUDAMED	Class III	Active
Z-Med	SO084	EUDAMED	Class III	Active
Z-Med Ii	PDZ627	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.