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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 (312)

Page 4 of 7

Device	Model / Reference	Registries	Class	Status
EXEL IV SET 15 DRP/mL, W/Y SITE, VENT/NON-VENT, 78" TUBE, LL	29082	EUDAMEDFDA UDI	Class IIa	Active
Exel Biopsy Punch, Ss, 4.0mm	29566	EUDAMEDFDA UDI	Class IIa	Active
EXEL 1mL TB 25G x 1"-0-DEAD-SPACE	26066	EUDAMEDFDA UDI	Class IIa	Active
EXEL 1mL TB 23G x 1"-0-DEAD-SPACE	26067	EUDAMEDFDA UDI	Class IIa	Active
Exel Spinal Ndl 23gx3-1/2"	26968	EUDAMEDFDA UDI	Class III	Active
Exel Iv Cath 20gx1-1/4"	26742	EUDAMED	Class IIa	Active
AmLUJECT DENTAL NDL. 30G X 21MM SHORT	90090	EUDAMEDFDA UDI	Class IIa	Active
EXEL Aluminum Hub Needles 14G X 1 1/2"	26452	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR 21GX1-1/2"	26107	EUDAMEDFDA UDI	Class IIa	Active
EXEL ComfortPoint Insulin Syringe - 0.5mL, 30G x 5/16"	26015	EUDAMED	Class IIa	Active
Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’	1001216	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR W/ SAFETY NDL 18GX1-1/2"	27110	EUDAMEDFDA UDI	Class IIa	Active
EXEL Aluminum Hub Needles 16G X 1"	26457	EUDAMEDFDA UDI	Class IIa	Active
Snap 1ml Luer Lock Syringe	26050SNAP	EUDAMEDFDA UDI	Class I	Active
Exel Spinal Ndl 24gx3-1/2"	26972	EUDAMEDFDA UDI	Class III	Active
EXEL Hypodermic Needle 22G x 1-1/2"	26412	EUDAMEDFDA UDI	Class IIa	Active
Exel 5ml Syringe L-L	26230BSNP	EUDAMEDFDA UDI	Class I	Active
Exel Biopsy Punch, Ss, 3.0mm	29564	EUDAMEDFDA UDI	Class IIa	Active
EXEL 1mL TB 25G X 5/8"-0-DEAD-SPACE	26046	EUDAMED	Class IIa	Active
EXEL 10-12mL AMBER SYR ONLY L-S W/ TIP CAP	26268	EUDAMEDFDA UDI	Class I	Active
Exel Hypo Ndl 18g X 1-1/2",	26420	EUDAMED	Class IIa	Active
EXEL 5-6mL SYR ONLY L-L	26230	EUDAMEDFDA UDI	Class I	Active
EXEL 10-12mL SYR 21GX1"	26252	EUDAMEDFDA UDI	Class IIa	Active
Exel Srgcl Blade, C-S, Size:11	29526	EUDAMEDFDA UDI	Class IIa	Active
EXEL ComfortPoint Insulin Syringe - 0.3mL, 30G x 1/2"	26019	EUDAMED	Class IIa	Active
Exel Hypo Ndl 30g X 1/2",	26437	EUDAMED	Class IIa	Active
Exel M-D Ndl 20gx1-1/2"	26502	EUDAMED	Class IIa	Active
EXEL Aluminum Hub Needles 16G X 3/4"	26456	EUDAMEDFDA UDI	Class IIa	Active
Exel Iv Cath 20gx2"	26743	EUDAMED	Class IIa	Active
Exel 10ml Syringe L-L	26265BSNP	EUDAMEDFDA UDI	Class I	Active
EXEL Catheter Tip Syringe, 30mL	26292	EUDAMEDFDA UDI	Class I	Active
EXEL Aluminum Hub Needles 20G X 1"	26467	EUDAMEDFDA UDI	Class IIa	Active
EXEL 1/2mL INS SYR 28GX1/2"	26024	EUDAMEDFDA UDI	Class IIa	Active
Exel Psv/M-S, L-A 21gx3/4"	26764	EUDAMED	Class IIa	Active
EXEL 10-12mL SYR 18GX1"	26257	EUDAMEDFDA UDI	Class IIa	Active
EXEL COMFORT POINT INSULIN PEN NDL 31G(0, 25)x1/3"(8mm)	26005	EUDAMED	Class IIa	Active
Exel Securetouch Safety Hypo Ndl 27gx1-1/2"	27426	EUDAMED	Class IIa	Active
Exel Securetouch Safety Hypo Ndl 23gx1"	27408	EUDAMED	Class IIa	Active
EXEL Holder with Luer Lock Multi Sample Luer Adapter	26532	EUDAMED	Class I	Active
Exel Spinal Ndl 25g X 3-1/2"	26970	EUDAMED	Class III	Active
EXEL 2-3mL SYR 25GX5/8"	26602	EUDAMEDFDA UDI	Class IIa	Active
Exel Scalpels , S-S, Size:11	29552	EUDAMEDFDA UDI	Class IIa	Active
EXEL Disposable Syringe with Needle, 1mL Luer Slip Tip W/ 25G x 1"	26042	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR 20GX1"	26611	EUDAMEDFDA UDI	Class IIa	Active
EXEL 5-6mL SYR 21GX1-1/2"	26213	EUDAMEDFDA UDI	Class IIa	Active
EXEL IV SET 60 DRP/mL, L-S W/Y SITE, VENT/NON-VENT, 78" TUBE	29083	EUDAMEDFDA UDI	Class IIa	Active
Exel Dermal Curette, Ss, 2.0mm	29580	EUDAMEDFDA UDI	Class IIa	Active
Exel Hypo Ndl 16g X 1",	26421	EUDAMEDFDA UDI	Class IIa	Active
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

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.

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