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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 8 of 11

Device	Model / Reference	Registries	Class	Status
Tyshak II	SO038	EUDAMED	Class III	Active
Bib	BB051	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN008	EUDAMED	Class III	Active
Tyshak	PDC142	EUDAMED	Class III	Active
Z-Med Ii	PDZ665	EUDAMED	Class III	Active
Z-Med Ii	PDZ656	EUDAMED	Class III	Active
NuCLEUS-X	PVN402	EUDAMED	Class III	Active
Z-Med Ii	SN042	EUDAMED	Class III	Active
Tyshak	PDC089	EUDAMED	Class III	Active
Tyshak	PDC191	EUDAMED	Class III	Active
Tyshak II	PDC510	EUDAMED	Class III	Active
Mullins-X	PTM451	EUDAMEDFDA 510(k)	Class III	Active
Z-Med Ii	PDZ674	EUDAMED	Class III	Active
Z-Med-X	PDZ401	EUDAMED	Class III	Active
COEfficient	COE108	EUDAMED	Class III	Active
Z-Med	SN021	EUDAMED	Class III	Active
Z-Med	SO057	EUDAMED	Class III	Active
Bib	BB026	EUDAMED	Class III	Active
Z-Med	SO060	EUDAMED	Class III	Active
Tyshak	PDC181	EUDAMED	Class III	Active
Tyshak-X	PDC333	EUDAMED	Class III	Active
NuCLEUS-X	PVN407	EUDAMED	Class III	Active
Z-Med Ii	PDZ630	EUDAMED	Class III	Active
Bib	BB017	EUDAMED	Class III	Active
Tyshak II	PDC527	EUDAMED	Class III	Active
Bib	BB077	EUDAMED	Class III	Active
Z-Med	SO082	EUDAMED	Class III	Active
Tyshak	PDC067	EUDAMED	Class III	Active
Z-Med Ii-X	PDZ743	EUDAMED	Class III	Active
Tyshak	PDC055	EUDAMED	Class III	Active
Tyshak	PDC076	EUDAMED	Class III	Active
Z-Med	PDZ365	EUDAMED	Class III	Active
Tyshak	PDC024	EUDAMED	Class III	Active
Tyshak	PDC008	EUDAMED	Class III	Active
Z-Med Ii	PDZ622	EUDAMED	Class III	Active
Z-Med	SO096	EUDAMED	Class III	Active
Tyshak II	SN009	EUDAMED	Class III	Active
Tyshak II	SO100	EUDAMED	Class III	Active
Tyshak II	SO021	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN010	EUDAMED	Class III	Active
Z-Med Ii	PDZ669	EUDAMED	Class III	Active
Tyshak II	PDC516	EUDAMED	Class III	Active
Z-Med Ii	PDZ626	EUDAMED	Class III	Active
Tyshak Mini	PDC404	EUDAMED	Class III	Active
Tyshak-X	PDC346	EUDAMED	Class III	Active
COEfficient	COE111	EUDAMED	Class III	Active
Tyshak	PDC169	EUDAMED	Class III	Active
Z-Med Ii	PDZ651	EUDAMED	Class III	Active
Tyshak	PDC157	EUDAMED	Class III	Active
Tyshak II	PDC552	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.