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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 7 of 11

Device	Model / Reference	Registries	Class	Status
COEfficient	COE126	EUDAMED	Class III	Active
Z-Med Ii	PDZ623	EUDAMED	Class III	Active
Tyshak	PDC083	EUDAMED	Class III	Active
Z-Med	PDZ317	EUDAMED	Class III	Active
Tyshak	PDC178	EUDAMED	Class III	Active
Z-Med-X	PDZ451	EUDAMED	Class III	Active
Tyshak	PDC019	EUDAMED	Class III	Active
Z-Med Ii	SO093	EUDAMED	Class III	Active
Z-Med Ii	SN036	EUDAMED	Class III	Active
Tyshak	PDC001	EUDAMED	Class III	Active
Tyshak	PDC134	EUDAMED	Class III	Active
Bib	BB076	EUDAMED	Class III	Active
Tyshak	PDC156	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN022	EUDAMED	Class III	Active
Bib	BB003	EUDAMED	Class III	Active
Tyshak	PDC197	EUDAMED	Class III	Active
Z-Med	SO055	EUDAMED	Class III	Active
Z-Med Ii-X	PDZ729	EUDAMED	Class III	Active
Tyshak II	PDC517	EUDAMED	Class III	Active
Z-Med-X	PDZ443	EUDAMED	Class III	Active
Tyshak II	SN007	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN009	EUDAMED	Class III	Active
Z-Med	SO067	EUDAMED	Class III	Active
Tyshak	PDC052	EUDAMED	Class III	Active
Tyshak	PDC029	EUDAMED	Class III	Active
Tyshak II	SO069	EUDAMED	Class III	Active
Tyshak II	PDC537	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN020	EUDAMED	Class III	Active
Tyshak II	PDC519	EUDAMED	Class III	Active
Tyshak	PDC078	EUDAMED	Class III	Active
Tyshak Mini	PDC403	EUDAMED	Class III	Active
Z-Med Ii	PDZ682	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN025	EUDAMED	Class III	Active
Tyshak	PDC051	EUDAMED	Class III	Active
Tyshak II	PDC523	EUDAMED	Class III	Active
Tyshak	PDC079	EUDAMED	Class III	Active
Z-Med	PDZ341	EUDAMED	Class III	Active
Tyshak	PDC108	EUDAMED	Class III	Active
Mullins-X	PTM442	EUDAMED	Class III	Active
Z-Med	PDZ356	EUDAMED	Class III	Active
Z-Med Ii	PDZ678	EUDAMED	Class III	Active
Bib	BB071	EUDAMED	Class III	Active
Reboa	RB203050	EUDAMEDFDA UDI	Class III	Active
Z-Med Ii	PDZ668	EUDAMED	Class III	Active
Tyshak-X	PDC320	EUDAMED	Class III	Active
Z-Med Ii	PDZ643	EUDAMED	Class III	Active
Z-Med	PDZ331	EUDAMED	Class III	Active
Tyshak	PDC020	EUDAMED	Class III	Active
Tyshak II	PDC508	EUDAMED	Class III	Active
Z-Med-X	PDZ440	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.