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ACME UNITED CORP.

US

Last updated September 17, 2026

What ACME UNITED CORP. makes

ACME United Corp. manufactures first aid supplies, including medicated and non-medicated kits (both reusable and single-use), woven gauze pads, skin-cover adhesive strips, endothermic cold therapy packs, finger stalls, and CPR mouthpiece/cover devices.

Their products are classified as Class I or exempt (N) under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from 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 types of medical devices does ACME United Corp. manufacture?

ACME United Corp. specializes in first aid supplies, including a variety of kits like medicated and non-medicated options (both reusable and single-use), as well as individual items such as woven gauze pads, skin-cover adhesive strips, endothermic cold therapy packs, finger stalls, and CPR mouthpiece/cover devices. These products are designed for emergency preparedness and basic medical care.

Where is ACME United Corp. based?

ACME United Corp. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.

How are ACME United Corp.’s devices classified under FDA regulations?

ACME United Corp.’s devices are classified as either Class I (general controls apply) or exempt (N) under FDA regulations. Class I devices are typically low-risk, while exempt devices are considered low enough risk that they don’t require premarket submission unless modified. This classification reflects the company’s focus on basic first aid and emergency response products.

Are ACME United Corp.’s devices listed in any regulatory registries?

Yes, ACME United Corp.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers and regulators.

Why are ACME United Corp.’s products primarily Class I or exempt?

ACME United Corp.’s devices are classified as Class I or exempt because they are designed for low-risk applications, such as first aid and emergency response. The FDA categorizes these products under general controls or exemptions when they pose minimal risk to patients, reducing the need for extensive regulatory oversight beyond standard manufacturing practices and labeling requirements.

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

Information

Country
US
Address
2280 Tanner Rd, Rocky Mount, NC, 27801
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
1030186
DUNS Number
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Catalogue (1498)

Page 26 of 30
DeviceModel / ReferenceRegistriesClassStatus
First Aid Only 54944
FDA UDI
NActive
First Aid Only 90813
FDA UDI
NActive
First Aid Only 90692
FDA UDI
NActive
First Aid Only 742028
FDA UDI
NActive
First Aid Only 59740
FDA UDI
NActive
First Aid Only 1-060
FDA UDI
Class IActive
First Aid Only FAE-3011
FDA UDI
Class IActive
First Aid Only 1-691
FDA UDI
Class IActive
First Aid Only 59946
FDA UDI
NActive
First Aid Only 59758
FDA UDI
NActive
First Aid Only 59177
FDA UDI
NActive
American Red Cross 9165-RC
FDA UDI
NActive
First Aid Only 59548
FDA UDI
NActive
First Aid Only 90638
FDA UDI
Class IActive
First Aid Only 59948
FDA UDI
NActive
First Aid Only 16VBP
FDA UDI
NActive
First Aid Only 90137
FDA UDI
NActive
First Aid Only 222-U/NORTHERN
FDA UDI
NActive
First Aid Only 710007
FDA UDI
NActive
First Aid Only 3-001
FDA UDI
Class IActive
First Aid Only 63ICC24
FDA UDI
NActive
First Aid Only 9195-SS
FDA UDI
NActive
First Aid Only 90672
FDA UDI
NActive
First Aid Only 90454
FDA UDI
NActive
First Aid Only 59141
FDA UDI
NActive
First Aid Only 91112
FDA UDI
NActive
First Aid Only 742020
FDA UDI
NActive
American Red Cross 720008
FDA UDI
NActive
First Aid Only 59863
FDA UDI
NActive
First Aid Only 90613
FDA UDI
NActive
First Aid Only 6430-1
FDA UDI
NActive
First Aid Only 16MSK
FDA UDI
NActive
First Aid Only 90717
FDA UDI
Class IActive
First Aid Only 742074
FDA UDI
NActive
First Aid Only 9071-SPI
FDA UDI
NActive
First Aid Only 90612
FDA UDI
NActive
First Aid Only 91325
FDA UDI
NActive
First Aid Only 21-027
FDA UDI
Class IActive
First Aid Only 59064
FDA UDI
NActive
First Aid Only 742056
FDA UDI
NActive
First Aid Only 919-ARB-R
FDA UDI
NActive
First Aid Only 36273
FDA UDI
NActive
First Aid Only 91341
FDA UDI
NActive
First Aid Only 59136
FDA UDI
NActive
First Aid Only B204
FDA UDI
Class IActive
First Aid Only 1-800
FDA UDI
Class IActive
First Aid Only 59722
FDA UDI
NActive
First Aid Only 90144-001
FDA UDI
NActive
First Aid Only 746004
FDA UDI
NActive
First Aid Only 21-026-001
FDA UDI
Class IActive

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