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Aso LLC

United States·US-MF-000008641

Last updated September 17, 2026

Information

Country: United States
Address: 300, Sarasota Center Blvd., Sarasota, United States
Website: www.asoeurope.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +31 24 343 54 80
PRRC Contact: Federico Juliao
EUDAMED SRN: US-MF-000008641
FDA FEI Number: 1038758
DUNS Number: 152793493

Catalogue (478)

Page 9 of 10

Device	Model / Reference	Registries	Class	Status
Garfield	017276222265	FDA UDI	Class I	Active
Crayola	017276237078	FDA UDI	Class I	Active
Care Band Adhesive Bandages	CBD4024	FDA UDI	Class I	Active
Clear Passage Nasal Strips	017276238877	FDA UDI	Class I	Active
Batman	017276238853	FDA UDI	Class I	Active
ALL-HEALTH Adhesive Bandages	017276234664	FDA UDI	N	Unknown
PJ Masks	017276237061	FDA UDI	Class I	Unknown
ALL-HEALTH Adhesive Bandages	017276233728	FDA UDI	Class I	Unknown
Carepak value pack	017276240689	FDA UDI	N	Active
CarePak	017276237894	FDA UDI	Class I	Active
ZAG Heroez Miraculous	017276238471	FDA UDI	Class I	Active
Sonic The Hedgehog	017276238464	FDA UDI	Class I	Active
CarePak	017276238280	FDA UDI	Class I	Active
ALL-HEALTH Wound Care Products	017276234411	FDA UDI	Class I	Active
PJ Masks	017276980233	FDA UDI	Class I	Unknown
Care Band Adhesive Bandages	CBD2016	FDA UDI	Class I	Active
LOL Surprise Antibacterial Bandages	017276236538	FDA UDI	Class I	Active
Clear Passage Nasal Strips	017276232974	FDA UDI	Class I	Active
Care Science	017276234763	FDA UDI	Class I	Active
ALL-HEALTH Hydrocolloid Gel Bandages	017276233872	FDA UDI	Class I	Unknown
DC League of Superpets	017276238792	FDA UDI	Class I	Active
Wonder Woman Adhesive Bandages	017276236859	FDA UDI	Class I	Unknown
Care Science	017276238976	FDA UDI	U	Active
Care Science	017276236071	FDA UDI	Class I	Unknown
InstaClear	017276233803	FDA UDI	Class I	Active
ALL-HEALTH Adhesive Bandages	017276234138	FDA UDI	Class I	Active
Urgo	UR-604257	EUDAMED	Class IIa	Active
Prontex	SAF-16804	EUDAMED	Class IIa	Active
Senti2	SEN-COS130	EUDAMED	Class IIa	Active
Kruidvat	KV-1118011	EUDAMED	Class I	Active
Flowplast	FLP-O82024	EUDAMED	Class IIa	Active
Prontex	SAF-16807	EUDAMED	Class IIa	Active
Apotek Hjärtats	APO-71750	EUDAMED	Class IIa	Active
Gehwol	GE-102762002	EUDAMED	Class IIa	Active
active MED	YM-1020022	EUDAMED	Class I	Active
Care Band Antibacterial Bandages	K983368	FDA 510(k)	Class I	Active
Adhesive Bandages	K932602	FDA 510(k)	Class I	Active
Cvs Silver Bandages, Walgreens Silver Bandages, Xyz Silver Bandages	K082910	FDA 510(k)	U	Active
Xyz Pads	K933159	FDA 510(k)	U	Active
Etos	ET-521850044	EUDAMED	Class IIa	Active
Urgo	UR-604412	EUDAMED	Class IIa	Active
Altapharma	ALT-070141	EUDAMED	Class I	Active
Airmax	AIR-7613	EUDAMED	Class I	Active
Zzzquill	ZQ-80814521	EUDAMED	Class I	Active
First Plast	GT-FP-3362	EUDAMED	Class I	Active
vidi Pharma	NMD-955599	EUDAMED	Class I	Active
Apotek Hjärtats	APO-75427	EUDAMED	Class IIa	Active
Apotek Hjärtat	APO-78200	EUDAMED	Class IIa	Active
First+plast	FP-3362	EUDAMED	Class I	Active
Deliplus	DEL-79668	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Aso Europe BV NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (15)

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
Mar 23, 2023	Z-1499-2023	—	open, classified	The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.
Jun 22, 2022	Z-1517-2022	—	open, classified	The product falls apart during handling after removal from its primary packaging.
Mar 2, 2022	Z-1031-2022	—	terminated	Kits contained recalled acetaminophen.
Oct 16, 2018	Z-0525-2019	—	open, classified	Potential that gauze pads may not be fully sterilized
Jun 10, 2015	Z-2460-2015	—	terminated	Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label.
Aug 21, 2013	Z-0004-2014	—	terminated	No antibacterial bandages were packed in boxes labeled as antibacterial.
Jul 26, 2013	Z-1890-2013	—	terminated	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Jul 26, 2013	Z-1892-2013	—	terminated	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Jul 26, 2013	Z-1891-2013	—	terminated	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Jul 26, 2013	Z-1894-2013	—	terminated	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Jul 26, 2013	Z-1893-2013	—	terminated	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Jul 26, 2013	Z-1895-2013	—	terminated	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Jul 26, 2013	Z-1896-2013	—	terminated	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Jul 26, 2013	Z-1889-2013	—	terminated	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
Jul 26, 2013	Z-1888-2013	—	terminated	This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.