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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 6 of 7

Device	Model / Reference	Registries	Class	Status
Exel Zorband Bandage, Ex-Large	26836	EUDAMEDFDA UDI	Class I	Active
EXEL Aluminum Hub Needles 20G X 5/8"	26465	EUDAMEDFDA UDI	Class IIa	Active
Exel Hypo Ndl 25g X 3/4",	26425	EUDAMEDFDA UDI	Class IIa	Active
EXEL ComfortPoint Insulin Syringe - 0.3mL, 30G x 5/16"	26014	EUDAMED	Class IIa	Active
EXEL 2-3mL SYR W/ SAFETY NDL 20GX1"	27108	EUDAMEDFDA UDI	Class IIa	Active
EXEL PSV SET 19GX3/4" with 12" TUBE,	26702	EUDAMED	Class IIa	Active
EXEL Hypodermic Needle 26Gx3/8"	26401	EUDAMEDFDA UDI	Class IIa	Active
EXEL ComfortPoint Insulin Syringe - 1mL, 28G x 1/2"	26027	EUDAMED	Class IIa	Active
EXEL Hypodermic Needle 23G x 1-1/2"	26409	EUDAMED	Class IIa	Active
EXEL 2-3mL SYR 23GX1"	26603	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR 22GX1"	26102	EUDAMEDFDA UDI	Class IIa	Active
EXEL Aluminum Hub Needles 16G X 5/8"	26455B	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR 25GX1-1/2"	26112	EUDAMEDFDA UDI	Class IIa	Active
Exel Hypo Ndl 20g X 1",	26417	EUDAMED	Class IIa	Active
Exel Srgcl Blade, C-S, Size:15	29532	EUDAMEDFDA UDI	Class IIa	Active
Exel Spinal Ndl 22gx1-1/2"	26966	EUDAMEDFDA UDI	Class III	Active
Exel Iv Cath 18gx2"	26738	EUDAMED	Class IIa	Active
EXEL IV SET 15 DRP/mL, W/Y SITE, VENT/NON-VENT, 78" TUBE, SLIP/LOCK CONNECTOR	29086	EUDAMEDFDA UDI	Class IIa	Active
Exel 5ml Clear Hldr	26530	EUDAMEDFDA UDI	Class I	Active
EXEL 10-12mL AMBER SYR ONLY L-L W/ TIP CAP	26269	EUDAMEDFDA UDI	Class I	Active
Exel Securetouch Safety Hypo Ndl 25g X 1-1/2"	27406	EUDAMED	Class IIa	Active
EXEL Hypodermic Needle 22G x 1-1/4"	26413	EUDAMEDFDA UDI	Class IIa	Active
Exel Biopsy Punch, Ss, 1.0mm	29560	EUDAMEDFDA UDI	Class IIa	Active
EXEL 1mL AMBER SYR ONLY LUER LOCK W/ TIP CAP	26039	EUDAMEDFDA UDI	Class I	Active
Exel, Exeflon 17g Iv Cannula W/ Injection Port	26593	EUDAMED	Class IIa	Active
EXEL Disposable Syringe with Needle, 1mL Luer Slip Tip W/ 27G x 1/2"	26040	EUDAMEDFDA UDI	Class IIa	Active
AmLUJECT DENTAL NDL. 25G X 21MM SHORT	90050	EUDAMEDFDA UDI	Class IIa	Active
Exel Blunt Tip Aluminum Sterile Hub Needle 18g X 1"	26473	EUDAMEDFDA UDI	Class IIa	Active
Exel Scalpels , S-S, Size:22	29559	EUDAMEDFDA UDI	Class IIa	Active
Exel Securetouch Safety Hypo Ndl 30gx1/2"	27437	EUDAMED	Class IIa	Active
Exel Spinal Ndl 21g X 3-1/2"	26971	EUDAMEDFDA UDI	Class III	Active
EXEL 2-3mL SYR W/ SAFETY NDL 25GX5/8"	27100	EUDAMEDFDA UDI	Class IIa	Active
EXEL 50-60mL SYR ONLY CATH TIP WITH CAP, BULK NON-STERILE;	26302BN	EUDAMEDFDA UDI	Class I	Active
EXEL Disposable Syringe, 1mL Luer Slip Tip W/ LDS Gasket	26048	EUDAMEDFDA UDI	Class I	Active
Exel 35ml Syringe L-L,	26290BSNP	EUDAMEDFDA UDI	Class I	Active
EXEL ComfortPoint Insulin Syringe - 0.5mL, 29G x 1/2"	26028	EUDAMED	Class IIa	Active
Exel Srgcl Blade, S-S, Size:11	29502	EUDAMEDFDA UDI	Class IIa	Active
EXEL Aluminum Hub Needles 18G X 1 1/2"	26464	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR 22GX3/4"	26601	EUDAMEDFDA UDI	Class IIa	Active
EXEL 5-6mL SYR 20GX1"	26214	EUDAMEDFDA UDI	Class IIa	Active
Exel Securetouch Safety Hypo Ndl 21g X 1-1/2"	27416	EUDAMED	Class IIa	Active
Exel Hypo Ndl 21g X 1-1/4	26415	EUDAMEDFDA UDI	Class IIa	Active
EXEL Hypodermic Needle 23G x 3/4"	26407	EUDAMED	Class IIa	Active
EXEL SecureTouch Safety Hypodermic Needle 25G x 5/8"	27403	EUDAMED	Class IIa	Active
Exel M-D Ndl 21gx1-1/2"	26504	EUDAMED	Class IIa	Active
EXEL Hypodermic Needle 22G x 1"	26411	EUDAMED	Class IIa	Active
EXEL Hypodermic Needle 27G x 1/2”	26400	EUDAMED	Class IIa	Active
Exel M-D Ndl 21gx1"	26503	EUDAMED	Class IIa	Active
EXEL Hypodermic Needle 23G x 1"	26408	EUDAMED	Class IIa	Active
Exel M-S L- Adapter	26537	EUDAMED	Class I	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 (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