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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 5 of 11

Device	Model / Reference	Registries	Class	Status
Z-Med Ii	SN041	EUDAMED	Class III	Active
Tyshak	PDC190	EUDAMED	Class III	Active
Z-Med-X	PDZ421	EUDAMED	Class III	Active
Bib	BB040	EUDAMED	Class III	Active
Z-Med	SO047	EUDAMED	Class III	Active
Tyshak II	SN006	EUDAMED	Class III	Active
Tyshak-X	PDC336	EUDAMED	Class III	Active
Tyshak	SN012	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN006	EUDAMED	Class III	Active
Z-Med Ii	PDZ649	EUDAMED	Class III	Active
Z-Med	PDZ323	EUDAMED	Class III	Active
Tyshak	PDC188	EUDAMED	Class III	Active
COEfficient	COE106	EUDAMED	Class III	Active
Bib	BB030	EUDAMED	Class III	Active
Tyshak-X	PDC314	EUDAMED	Class III	Active
Mullins-X	PTM441	EUDAMED	Class III	Active
Z-Med	SO099	EUDAMED	Class III	Active
Z-Med Ii	PDZ620	EUDAMED	Class III	Active
Tyshak	PDC063	EUDAMED	Class III	Active
Z-Med	PDZ332	EUDAMED	Class III	Active
Z-Med Ii-X	PDZ744	EUDAMED	Class III	Active
Tyshak	PDC118	EUDAMED	Class III	Active
Z-Med-X	PDZ415	EUDAMED	Class III	Active
Tyshak-X	PDC319	EUDAMED	Class III	Active
Tyshak	PDC087	EUDAMED	Class III	Active
Bib	BB041	EUDAMED	Class III	Active
Bib	BB038	EUDAMED	Class III	Active
Mullins-X	PTM444	EUDAMED	Class III	Active
Tyshak	PDC025	EUDAMED	Class III	Active
Tyshak	PDC013	EUDAMED	Class III	Active
Z-Med Ii	PDZ629	EUDAMED	Class III	Active
Z-Med Ii-X	PDZ702	EUDAMED	Class III	Active
Z-Med Ii	SO079	EUDAMED	Class III	Active
Tyshak	PDC136	EUDAMED	Class III	Active
Tyshak-X	PDC310	EUDAMED	Class III	Active
Bib	BB021	EUDAMED	Class III	Active
Z-Med	SO006	EUDAMED	Class III	Active
Z-Med-X	PDZ436	EUDAMED	Class III	Active
Z-Med	PDZ374	EUDAMED	Class III	Active
Z-Med Ii	PDZ645	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN035	EUDAMED	Class III	Active
Z-Med	PDZ351	EUDAMED	Class III	Active
Z-Med	PDZ305	EUDAMED	Class III	Active
Z-Med	SO076	EUDAMED	Class III	Active
Z-Med	SO062	EUDAMED	Class III	Active
COEfficient	COE133	EUDAMED	Class III	Active
Tyshak-X	PDC303	EUDAMED	Class III	Active
COEfficient	COE105	EUDAMED	Class III	Active
Z-Med Ii-X	PDZ711	EUDAMED	Class III	Active
Tyshak	PDC058	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.