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Exelint International, Co.

United States·US-MF-000037396

Last updated September 17, 2026

What Exelint International, Co. makes

Exelint International, Co. manufactures single-use medical devices including hypodermic needles, manual scalpel blades, dermal curettes, and scalpels. Their product portfolio also includes disposable syringes, injection plugs, IV sets, IV cannulas with injection ports, biopsy punches, and anesthesia sets.

The company's devices are classified as Class I, Class II, Class III, and Class IIa, and are listed in the EUDAMED and FDA 510(k) registries. Exelint International, Co. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does Exelint International, Co. manufacture?

Exelint International, Co. produces single-use medical devices including hypodermic needles, manual scalpel blades, dermal curettes, scalpels, disposable syringes, injection plugs, IV sets, IV cannulas with injection ports, biopsy punches, and anesthesia sets.

Where is Exelint International, Co. based?

Exelint International, Co. is based in the United States, as indicated in the provided device data.

Which regulatory registries list Exelint International, Co.'s devices?

Exelint International, Co.'s devices are listed in the EUDAMED and FDA 510(k) registries, as specified in the device data.

How are Exelint International, Co.'s devices classified?

Exelint International, Co.'s devices are classified as Class I, Class II, Class III, and Class IIa, according to the regulatory classifications provided in the device data.

AI-generated from registry data and not verified by a human reviewer.

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 (322)

Page 5 of 7

Device	Model / Reference	Registries	Class	Status
Exel Blunt Tip Aluminum Sterile Hub Needle 17g X 1 1/2"	26472	EUDAMEDFDA UDI	Class IIa	Active
Holder with Luer Lock Multi Sample Luer Adapter	26532BN	EUDAMEDFDA UDI	Class I	Active
EXEL Hypodermic Needle 25G x 1"	26405	EUDAMED	Class IIa	Active
Exel 30" Extension Set, W/Luer Slip	1730	EUDAMEDFDA UDI	Class I	Active
EXEL 1mL SYR W/ SAFETY NDL 25GX1-1/2"	27046	EUDAMEDFDA UDI	Class IIa	Active
EXEL 20-25mL AMBER SYR ONLY L-L W/ TIP CAP	26289	EUDAMEDFDA UDI	Class I	Active
EXEL 2-3mL SYR W/ SAFETY NDL 23GX5/8"	27118	EUDAMEDFDA UDI	Class IIa	Active
EXEL HYPO NDL 16Gx3/4",	26423	EUDAMEDFDA UDI	Class IIa	Active
AmLUJECT DNTL NDL. 30G X 12MM X-SHORT	90010	EUDAMEDFDA UDI	Class IIa	Active
EXEL ComfortPoint Insulin Syringe - 1mL, 31G x 5/16"	26012	EUDAMED	Class IIa	Active
Exel, Exeflon 18g Iv Cannula W/ Injection Port	26524	EUDAMED	Class IIa	Active
EXEL 2-3mL AMBER SYR ONLY L-S W/ TIP CAP	26208	EUDAMEDFDA UDI	Class I	Active
Exel Hypo Ndl 30gx1",	26439	EUDAMED	Class IIa	Active
Exel Srgcl Blade, S-S, Size:12	29504	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR W/ SAFETY NDL 21GX1-1/2"	27107	EUDAMEDFDA UDI	Class IIa	Active
EXEL COMFORT POINT INSULIN PEN NDL 31G(0, 25)x5/32"(4mm)	26006	EUDAMED	Class IIa	Active
EXEL 1mL ALLERGY SYR 27GX1/2"	26062	EUDAMEDFDA UDI	Class IIa	Active
EXEL 5-6mL AMBER SYR ONLY L-S W/ TIP CAP	26238	EUDAMEDFDA UDI	Class I	Active
Exel Safety Iv Cath 24gx3/4"	27751	EUDAMED	Class IIa	Active
EXEL 2-3mL SYR 22GX1"	26605	EUDAMEDFDA UDI	Class IIa	Active
EXEL 1mL LDS SYR 20G x 1"	26059	EUDAMEDFDA UDI	Class IIa	Active
EXEL 20-25ml SYR L-L W/ ALUMINUM HUB NDL	26279	EUDAMEDFDA UDI	Class I	Active
EXEL 10-12mL SYR 20GX1-1/2"	26255	EUDAMEDFDA UDI	Class IIa	Active
Exel Hypo Ndl 18g X 1",	26419	EUDAMED	Class IIa	Active
EXEL Aluminum Hub Needles 18G X 3/4"	26461	EUDAMEDFDA UDI	Class IIa	Active
EXEL 1mL INS 28GX1/2"	26034	EUDAMEDFDA UDI	Class IIa	Active
Exel Iv Cath 22gx1"	26746	EUDAMED	Class IIa	Active
Exel Spinal Ndl 30gx3-1/2"	26976	EUDAMEDFDA UDI	Class III	Active
EXEL 5-6mL SYR 22GX1-1/4"	26219	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR 22GX1-1/4"	26103	EUDAMEDFDA UDI	Class IIa	Active
Exel, Exeflon 18g Iv Cannula W/ Injection Port	26594	EUDAMED	Class IIa	Active
Exel Iv Cath 24gx3/4"	26751	EUDAMED	Class IIa	Active
EXEL 30-35mL SYR ONLY L-S	26291	EUDAMEDFDA UDI	Class I	Active
EXEL ComfortPoint Insulin Syringe - 0.3mL, 29G x 1/2"	26018	EUDAMED	Class IIa	Active
EXEL COMFORT POINT INSULIN PEN NDL 29G(0, 33)x1/2"(12mm)	26003	EUDAMED	Class IIa	Active
EXEL 2-3mL SYR 23GX1-1/2"	26117	EUDAMEDFDA UDI	Class IIa	Active
Exel Abs M-S L- Adapter	26536	EUDAMEDFDA UDI	Class I	Active
Exel Securetouch Safety Hypo Ndl 18gx1-1/2"	27420	EUDAMED	Class IIa	Active
EXEL 2-3mL SYR 21GX1"	26608	EUDAMEDFDA UDI	Class IIa	Active
Exel Securetouch Safety Hypo Ndl 27g X 1-1/4"	27427	EUDAMED	Class IIa	Active
EXEL 2-3mL SYR W/ SAFETY NDL 21GX1"	27105	EUDAMEDFDA UDI	Class IIa	Active
EXEL 5-6mL SRY ONLY	26230BS	EUDAMEDFDA UDI	Class I	Active
EXEL 1mL TB 21Gx1"-0-DEAD-SPACE	26051	EUDAMEDFDA UDI	Class IIa	Active
Exel Biopsy Punch, Ss, 2.5mm	29563	EUDAMEDFDA UDI	Class IIa	Active
EXEL Disposable Syringe with Needle, 3mL Luer Lock Tip W/ 25G x 5/8"	26101	EUDAMEDFDA UDI	Class IIa	Active
Exel Hypo Ndl 28g X 3/4"	26448B	EUDAMEDFDA UDI	Class IIa	Active
Exel 12" Extension Set, W/Luer Slip	1712	EUDAMEDFDA UDI	Class I	Active
EXEL 2-3mL SYR W/ SAFETY NDL 25GX1"	27111	EUDAMEDFDA UDI	Class IIa	Active
EXEL Hypodermic Needle 21G x 1-1/2"	26416	EUDAMED	Class IIa	Active
AmLUJECT DENTAL NDL. 27G X 21MM SHORT	90070	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

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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.

Exelint International, Co. has 3 recall records, all initiated on 2009-12-23 and terminated. The recalls were for non-coring needles that were shown to core the silicone port's septum, which may lead to decreased effectiveness of the port, infection, necrosis, swelling, and embolization, potentially resulting in pulmonary embolism, limb ischemia, stroke, or local extravasation of medication.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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