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EPIMED INTERNATIONAL, INC.

United States·US-MF-000010774

Last updated September 17, 2026

Information

Country: United States
Address: 13958, Diplomat Drive, Farmers Branch, United States
Website: epimed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Preston Frasier
EUDAMED SRN: US-MF-000010774
FDA FEI Number: 1316297
DUNS Number: —

Catalogue (191)

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
Epimed International, Inc.	115-2260	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	262-2215	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	286-2010	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	257-2015	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	240-2210	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	126-2045	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	117-2230	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	106-1418	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	243-1810	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	138-1427	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	267-2010	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	116-2080	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	105-1418	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	258-2005	EUDAMED	Class IIa	Active
Epimed International, Inc.	267-2215	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	241-1810	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	105-1518	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	105-1614	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	282-2015	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	286-2210	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	266-2015	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	120-2535	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	281-2205	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	125-1735T	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	240-2010	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	107-1418	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	106-1516	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	281-2210	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	105-1415	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	105-1615	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	267-2210	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	107-1618	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	126-1835	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	243-2015	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	282-2210	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	262-2015	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	126-1845	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	100-1416	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	105-1218	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	116-2260	EUDAMEDFDA UDI	Class IIa	Active
Epimed International, Inc.	119-2080	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (11)

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
Feb 1, 2021	Z-1276-2021	—	terminated	Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Feb 21, 2020	Z-1849-2020	—	terminated	Incorrect expiration date on introduction cannula packaging.
Feb 21, 2020	Z-1850-2020	—	terminated	Incorrect expiration date on introduction cannula packaging.
Jun 18, 2019	Z-2068-2019	—	terminated	Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
Jun 18, 2019	Z-2069-2019	—	terminated	Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
Dec 28, 2017	Z-2313-2021	—	completed	Potential for stylet to protrude from the distal end of the catheter
Dec 28, 2017	Z-2312-2021	—	completed	Potential for stylet to protrude from the distal end of the catheter
Jul 24, 2017	Z-0087-2018	—	terminated	Potential for partially incomplete seal of product, impacting sterility.
Jul 24, 2017	Z-0088-2018	—	terminated	Potential for partially incomplete seal of product, impacting sterility.
Jul 24, 2017	Z-0089-2018	—	terminated	Potential for partially incomplete seal of product, impacting sterility.
Apr 22, 2016	Z-0086-2017	—	terminated	There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.