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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 3 of 7

Device	Model / Reference	Registries	Class	Status
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
Exel 3ml Syringe L-L	26200BSNP	EUDAMEDFDA UDI	Class I	Active
EXEL 1ml Syringe 23G x 1" LDS	26057	EUDAMEDFDA UDI	Class IIa	Active
EXEL 5-6mL AMBER SYR ONLY L-L W/ TIP CAP	26239	EUDAMEDFDA UDI	Class I	Active
EXEL Aluminum Hub Needles 16G X 1 1/2"	26458	EUDAMEDFDA UDI	Class IIa	Active
Exel 20" Extension Set W/Y, W/Luer Slip	1720WY	EUDAMEDFDA UDI	Class I	Active
Exel Zorband Bandage, Large	26834	EUDAMEDFDA UDI	Class I	Active
EXEL 1/2mL INS SYR 29GX1/2"	26028BN	EUDAMEDFDA UDI	Class IIa	Active
EXEL PSV SET 25GX3/4" with 12" TUBE	26708	EUDAMED	Class IIa	Active
Exel Safety Iv Cath 14gx1-1/4"	27726	EUDAMED	Class IIa	Active
EXEL Aluminum Hub Needles 20G X 1 1/2"	26468	EUDAMEDFDA UDI	Class IIa	Active
Exel Hypo Ndl 19g X 1",	26424	EUDAMED	Class IIa	Active
EXEL 2-3mL SYR W/ SAFETY NDL 22GX1-1/2"	27104	EUDAMEDFDA UDI	Class IIa	Active
Exel Srgcl Blade, S-S, Size:20	29512	EUDAMEDFDA UDI	Class IIa	Active
EXEL Hypodermic Needle 22G x 3/4"	26410	EUDAMED	Class IIa	Active
EXEL ComfortPoint Insulin Syringe - 0.3mL, 28G x 1/2"	26017	EUDAMED	Class IIa	Active
Exel Dermal Curette, Ss, 4.0mm	29582	EUDAMEDFDA UDI	Class IIa	Active
Exel Srgcl Blade, S-S, Size:22	29515	EUDAMEDFDA UDI	Class IIa	Active
EXEL 105" IV ADMIN SET, 15 DROP W/ 2 Y INJECTION SITES, 2 OmLLUSION CLAMPS, ROLLER CLAMP AND SLIP-LOCK CONNECTOR	29088	EUDAMEDFDA UDI	Class IIa	Active
EXEL Disposable Syringe with Needle, 1mL Luer Slip Tip W/ 26G x 1/2"	26043	EUDAMEDFDA UDI	Class IIa	Active
EXEL ComfortPoint Insulin Syringe - 1mL, 30G x 5/16"	26016	EUDAMED	Class IIa	Active
Exel Spinal Ndl 20gx3-1/2"	26964	EUDAMED	Class III	Active
Exel Scalpels , S-S, Size:10	29550	EUDAMEDFDA UDI	Class IIa	Active
EXEL Hypodermic Needle 21G x 1"	26414	EUDAMED	Class IIa	Active
Exel Dntl Ndl 30g Short	26555	EUDAMEDFDA UDI	Class IIa	Active
EXEL 2-3mL SYR ONLY L-L	26200BS	EUDAMEDFDA UDI	Class I	Active
Exel Iv Cath 14gx1-1/4"	26726	EUDAMED	Class IIa	Active
Exel, Exeflon 16g Iv Cannula W/ Injection Port	26522	EUDAMED	Class IIa	Active
EXEL 10-12mL SYR ONLY L-S	26266	EUDAMEDFDA UDI	Class I	Active
Exel Hypo Ndl 20g X 1/2",	26431	EUDAMED	Class IIa	Active
EXEL 30-35mL SYR ONLY L-L	26290	EUDAMEDFDA UDI	Class I	Active
Exel, Exeflon 20g Iv Cannula W/ Injection Port	26525	EUDAMED	Class IIa	Active
Exel Hypo Ndl 20g X 1-1/2",	26418	EUDAMED	Class IIa	Active
EXEL CURVED TIP 10ml SYRINGE	26267	EUDAMEDFDA UDI	Class I	Active
Exel Biopsy Punch, Ss, 8.0mm	29570	EUDAMEDFDA UDI	Class IIa	Active
Exel Hypo Ndl 20g X 2"	26460	EUDAMEDFDA UDI	Class IIa	Active
Exel Iv Cath 18gx1-1/4"	26735	EUDAMED	Class IIa	Active
Exel, Exeflon 24g Iv Cannula W/ Injection Port	26527	EUDAMED	Class IIa	Active
Exel Abs M-S L- Adapter	26536BS	EUDAMEDFDA UDI	Class I	Active
EXEL Hypodermic Needle 26G x 1/2"	26402	EUDAMED	Class IIa	Active
Exel, Exeflon 20g Iv Cannula W/ Injection Port	26595	EUDAMED	Class IIa	Active
EXEL Aluminum Hub Needles 14G X 2"	26454	EUDAMEDFDA UDI	Class IIa	Active
EXEL 20-25mL SYR ONLY	26280	EUDAMEDFDA UDI	Class I	Active
EXEL 50-60mL SYR ONLY L-S ECC	26301	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