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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 12 of 30
DeviceModel / ReferenceRegistriesClassStatus
First Aid Only 59156
FDA UDI
NActive
First Aid Only 1-040
FDA UDI
Class IActive
First Aid Only 59140
FDA UDI
NActive
First Aid Only 64GE
FDA UDI
Class IActive
First Aid Only 59414
FDA UDI
NActive
First Aid Only FAO-130-KC
FDA UDI
NActive
First Aid Only 59161
FDA UDI
NActive
First Aid Only RC-608
FDA UDI
NActive
First Aid Only 91095
FDA UDI
NActive
First Aid Only 59761
FDA UDI
NActive
First Aid Only 710024
FDA UDI
NActive
First Aid Only FAE-7022
FDA UDI
Class IActive
First Aid Only 6175NEIS/R
FDA UDI
NActive
First Aid Only 90765
FDA UDI
NActive
First Aid Only 59353
FDA UDI
NActive
First Aid Only 742070
FDA UDI
NActive
First Aid Only 71-070
FDA UDI
Class IActive
First Aid Only 91058
FDA UDI
NActive
First Aid Only 59880
FDA UDI
NActive
First Aid Only 91144
FDA UDI
Class IActive
First Aid Only 7110
FDA UDI
NActive
First Aid Only 59934
FDA UDI
NActive
First Aid Only 60HS86
FDA UDI
NActive
First Aid Only 1-009
FDA UDI
Class IActive
First Aid Only 59473
FDA UDI
NActive
First Aid Only 38000
FDA UDI
NActive
First Aid Only 9401-50P-AWC
FDA UDI
NActive
First Aid Only 90950
FDA UDI
NActive
First Aid Only 225-AN
FDA UDI
NActive
First Aid Only 91300
FDA UDI
NActive
First Aid Only 9099-MOTURIS
FDA UDI
NActive
First Aid Only 59884
FDA UDI
NActive
First Aid Only 3-014
FDA UDI
Class IActive
First Aid Only 5-003
FDA UDI
Class IActive
First Aid Only 59450
FDA UDI
NActive
First Aid Only 59703
FDA UDI
NActive
First Aid Only 52SSC
FDA UDI
NActive
First Aid Only 92100
FDA UDI
Class IActive
First Aid Only 90586
FDA UDI
NActive
First Aid Only 59895
FDA UDI
NActive
First Aid Only 54023
FDA UDI
NActive
First Aid Only 6060
FDA UDI
NActive
First Aid Only 59962
FDA UDI
NActive
First Aid Only G121
FDA UDI
Class IActive
First Aid Only 59728
FDA UDI
NActive
First Aid Only 90603
FDA UDI
NActive
First Aid Only 90785
FDA UDI
NActive
First Aid Only 710037
FDA UDI
NActive
First Aid Only 9400-25P-NDC
FDA UDI
NActive
First Aid Only 59774
FDA UDI
NActive

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