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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 (192)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Epimed	261-2210	FDA UDI	Class II	Active
Epimed	265-2210	FDA UDI	Class II	Unknown
Epimed	154-1912	FDA UDI	Class II	Active
Epimed	1911-421	FDA UDI	Class II	Active
Epimed International, Inc.	181-2112	FDA UDI	Class II	Active
Epimed	410-146T	FDA UDI	Class II	Active
Epimed	175-2024	FDA UDI	Class II	Unknown
Epimed	420-PBGP	FDA UDI	Class II	Active
Epimed	173-2024	FDA UDI	Class II	Unknown
Epimed	400-PBSYS	FDA UDI	Class II	Active
Epimed	410-163T	FDA UDI	Class II	Active
Epimed	268-2015	FDA UDI	Class II	Unknown
Epimed	107-1313	FDA UDI	Class II	Active
Epimed	286-2215	FDA UDI	Class II	Unknown
Epimed	157-1912	FDA UDI	Class II	Unknown
Epimed	106-1515	FDA UDI	Class II	Unknown
Epimed	176-2024	FDA UDI	Class II	Unknown
Epimed	410-186T	FDA UDI	Class II	Active
Epimed International, Inc.	197-3522	FDA UDI	Class II	Active
Epimed	130-2245	FDA UDI	Class II	Active
Epimed	1911-498	FDA UDI	Class II	Active
Epimed	268-2210	FDA UDI	Class II	Unknown
Epimed	120-2225	FDA UDI	Class II	Active
Epimed	189-2340	FDA UDI	Class II	Unknown
Epimed	131-2545	FDA UDI	Class II	Active
Epimed	176-1924	FDA UDI	Class II	Unknown
Epimed	155-1353	FDA UDI	Class II	Unknown
Epimed	121-2525	FDA UDI	Class II	Active
Epimed	410-182T	FDA UDI	Class II	Active
Epimed	193-2024	FDA UDI	Class II	Unknown
Epimed	290-GPC04	FDA UDI	Class II	Unknown
Epimed	192-2024	FDA UDI	Class II	Unknown
Epimed	155-2550	FDA UDI	Class II	Active
Epimed	153-2540	FDA UDI	Class II	Active
Epimed	179-2340	FDA UDI	Class II	Unknown
Epimed	188-2260	FDA UDI	Class II	Unknown
Epimed	175-1924	FDA UDI	Class II	Unknown
Epimed	301-1815	FDA UDI	Class II	Active
Epimed	231-1615	FDA UDI	Class II	Unknown
Epimed	121-2225	FDA UDI	Class II	Active
Epimed	188-2340	FDA UDI	Class II	Unknown
Epimed International, Inc.	197-3520	FDA UDI	Class II	Active
Epimed	155-2340	FDA UDI	Class II	Active
Epimed International, Inc.	181-2340	FDA UDI	Class II	Active
Epimed	220-1810	FDA UDI	Class II	Active
Epimed	233-1615	FDA UDI	Class II	Unknown
Epimed	1911-600	FDA UDI	Class II	Active
Epimed	281-2215	FDA UDI	Class II	Unknown
Epimed	291-C04	FDA UDI	Class II	Active
Epimed	191-750	FDA UDI	Class II	Unknown

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.