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Exelint International, Co.

United States·US-MF-000037396

Last updated September 17, 2026

Information

Country: United States
Address: 2500, Santa Fe Ave., Redondo Beach, United States
Website: www.exelmedintl.com
LinkedIn: linkedin.com/company/exelintinternational
Facebook: facebook.com/exelintinternational
Email: [email protected]
Phone: +1-310-649-0707
PRRC Contact: Vu Doan
EUDAMED SRN: US-MF-000037396
FDA FEI Number: 1035907
DUNS Number: —

Catalogue (312)

Page 2 of 7

Device	Model / Reference	Registries	Class	Status
Exel Secure Touch Safety (p.s.v.) Scalp Vein Set	K010197	FDA 510(k)	Class II	Active
Exel Butterfly Scalp Vein Set	K020189	FDA 510(k)	Class II	Active
Exel Secure Touch Safety A.v. Fistula Needle Set	K003627	FDA 510(k)	Class II	Active
A.v. Fistula Needle	K001496	FDA 510(k)	Class II	Active
Exel 5ml Clear Hldr	26531	EUDAMEDFDA UDI	Class I	Active
EXEL 2-3mL SYR 20G X1-1/2"	26109	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR 27GX1-1/4"	26129	EUDAMEDFDA UDI	Class IIa	Active
EXEL PSV SET 21GX3/4" with 12" TUBE	26704	EUDAMED	Class IIa	Active
EXEL 1ml Syringe 25G x 1" LDS	26056	EUDAMEDFDA UDI	Class IIa	Active
Exel Blunt Tip Aluminum Sterile Hub Needle 19 Gx 1 1/2"	26474	EUDAMEDFDA UDI	Class IIa	Active
Exel Spinal Ndl 26g X 3-1/2"	26973	EUDAMEDFDA UDI	Class III	Active
EXEL 20-25mL AMBER SYR ONLY L-S W/ TIP CAP	26288	EUDAMEDFDA UDI	Class I	Active
EXEL Aluminum Hub Needles, 14G X 1"	26450	EUDAMEDFDA UDI	Class IIa	Active
Exel Dehp-Free Primary Solution Set	26085	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR W/ SAFETY NDL 23GX1"	27101	EUDAMEDFDA UDI	Class IIa	Active
EXEL 1mL SYR W/ SAFETY NDL 25GX1"	27045	EUDAMEDFDA UDI	Class IIa	Active
EXEL 10-12mL SYR 22GX1-1/2"	26251	EUDAMEDFDA UDI	Class IIa	Active
EXEL 1mL LDS SYR ONLY LUER LOCK, W/ CAP	26049	EUDAMEDFDA UDI	Class I	Active
EXEL 2-3mL SYR ONLY L-S	26201	EUDAMEDFDA UDI	Class I	Active
Exel Spinal Ndl 29g X 3-1/2"	26975	EUDAMEDFDA UDI	Class III	Active
EXEL 5-6mL SYR 21GX1-1/4"	26218	EUDAMEDFDA UDI	Class IIa	Active
EXEL ComfortPoint Insulin Syringe - 0.3mL, 31G x 5/16"	26010	EUDAMED	Class IIa	Active
Exel Spinal Ndl 22g X 2 3/4"	26965	EUDAMED	Class III	Active
Exel, Exeflon 24g Iv Cannula W/ Injection Port	26597	EUDAMED	Class IIa	Active
Exel Blunt Tip Aluminum Sterile Hub Needle 20g X 1 1/2"	26475	EUDAMEDFDA UDI	Class IIa	Active
Exel Spinal Ndl 27g X 3-1/2"	26969	EUDAMEDFDA UDI	Class III	Active
EXEL SecureTouch Safety Hypodermic Needle 25G x 1"	27405	EUDAMED	Class IIa	Active
EXEL PSV SET 23GX3/4" with 12" TUBE	26706	EUDAMED	Class IIa	Active
EXEL Aluminum Hub Needles 20G X 1/2"	26466	EUDAMEDFDA UDI	Class IIa	Active
EXEL 10-12mL SYR 21GX1-1/2"	26253	EUDAMEDFDA UDI	Class IIa	Active
EXEL BLUNT TIP ALUMINUM STERILE HUB NEEDLE 15G x 1 1/2"	26471	EUDAMEDFDA UDI	Class IIa	Active
Tandem Diabetes 3mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’	1001215	EUDAMEDFDA UDI	Class IIa	Active
EXEL Aluminum Hub Needles, 14G X 3/4"	26415	EUDAMEDFDA UDI	Class IIa	Active
EXEL 30-35mL SYR CATH.	26292BN	EUDAMEDFDA UDI	Class I	Active
EXEL 10-12mL SYR 22GX1"	26250	EUDAMEDFDA UDI	Class IIa	Active
Exel Hypo Ndl 28g X 3/4"	26448	EUDAMED	Class IIa	Active
Exel Dermal Curette, Ss, 3.0mm	29581	EUDAMEDFDA UDI	Class IIa	Active
EXEL 20-25mL SYR ONLY L-S	26281	EUDAMEDFDA UDI	Class I	Active
EXEL IV SET 60 DRP/mL, W/Y SITE, VENT/NON-VENT, 78" TUBE, LL	29085	EUDAMEDFDA UDI	Class IIa	Active
Exel Scalpels , S-S, Size:15	29556	EUDAMEDFDA UDI	Class IIa	Active
EXEL 1mL CARRYING AND DELIVERY SYRINGE;	OSTDS1	EUDAMEDFDA UDI	Class I	Active
EXEL U-40 1/2mL INS SYR 29GX1/2"	26036	EUDAMEDFDA UDI	Class IIa	Active
Exel 50ml Syringe L-L	26300BSNP	EUDAMEDFDA UDI	Class I	Active
AmLUJECT DENTAL NDL. 27G X 32MM LONG	90080	EUDAMEDFDA UDI	Class IIa	Active
Multi-Sample Blood Collection Needle 18G X 1"	26500	EUDAMED	Class IIa	Active
EXEL Aluminum Hub Needles 18G X 1"	26462	EUDAMEDFDA UDI	Class IIa	Active
EXEL PSV SET 27GX3/4" with 12" TUBE	26709	EUDAMED	Class IIa	Active
Hypo Ndl 32g X 1/2";	26392S	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR W/ SAFETY NDL 23GX1-1/2"	27117	EUDAMEDFDA UDI	Class IIa	Active
Exel M-D Ndl 20gx1"	26501	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (3)

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
Dec 23, 2009	Z-0638-2010	—	terminated	Non-coring needles that, when inserted into an implanted port, were shown to core the silicone port's septum. Coring of port's septum may lead to: decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in pulmonary embolism, limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material; may lead to local tissue
Dec 23, 2009	Z-0639-2010	—	terminated	Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port
Dec 23, 2009	Z-0640-2010	—	terminated	Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port