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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 21 of 30
DeviceModel / ReferenceRegistriesClassStatus
First Aid Only 90929
FDA UDI
NActive
First Aid Only 700001
FDA UDI
NActive
First Aid Only 90783
FDA UDI
NActive
First Aid Only 59508
FDA UDI
NActive
First Aid Only 59340
FDA UDI
Class IActive
First Aid Only 90965
FDA UDI
NActive
First Aid Only 90698
FDA UDI
NActive
First Aid Only 5-6800
FDA UDI
Class IActive
First Aid Only 16NMC
FDA UDI
NActive
First Aid Only 90766
FDA UDI
NActive
First Aid Only 54020
FDA UDI
NActive
First Aid Only 5-900
FDA UDI
Class IActive
First Aid Only 59762
FDA UDI
NActive
First Aid Only 59584
FDA UDI
NActive
First Aid Only 9300-10P-AWC
FDA UDI
NActive
First Aid Only 59451
FDA UDI
NActive
First Aid Only H125
FDA UDI
Class IActive
First Aid Only M5107
FDA UDI
NActive
First Aid Only 59757
FDA UDI
NActive
First Aid Only FAO-432
FDA UDI
NActive
First Aid Only 12302
FDA UDI
Class IActive
First Aid Only 91038
FDA UDI
Class IActive
American Red Cross 720010
FDA UDI
NActive
First Aid Only 91138
FDA UDI
Class IActive
First Aid Only H107
FDA UDI
Class IActive
First Aid Only 90399
FDA UDI
NActive
First Aid Only 91389
FDA UDI
NActive
First Aid Only FAE-3006
FDA UDI
Class IActive
First Aid Only G127
FDA UDI
Class IActive
First Aid Only 59219
FDA UDI
NActive
First Aid Only 1350-MCH-0108
FDA UDI
NActive
First Aid Only 91349
FDA UDI
NActive
First Aid Only 91328
FDA UDI
NActive
First Aid Only 5-600
FDA UDI
Class IActive
First Aid Only 1-750
FDA UDI
Class IActive
First Aid Only 91379
FDA UDI
NActive
First Aid Only 6410
FDA UDI
NActive
First Aid Only 36694CPR
FDA UDI
NActive
First Aid Only 90594
FDA UDI
NActive
First Aid Only 6084CPR
FDA UDI
NActive
First Aid Only 3300IK/FS
FDA UDI
NActive
First Aid Only 63AMT10
FDA UDI
NActive
First Aid Only 59423
FDA UDI
NActive
First Aid Only H245
FDA UDI
Class IActive
First Aid Only 59151
FDA UDI
NActive
First Aid Only 59120
FDA UDI
NActive
First Aid Only 59889
FDA UDI
NActive
First Aid Only 54911
FDA UDI
NActive
First Aid Only 223-G
FDA UDI
NActive
First Aid Only 91035
FDA UDI
Class IActive

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