Is this your brand? Sign in to claim ownership.
Sign in to claim this brandACME 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
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1030186
- DUNS Number
- —
Catalogue (1498)
Page 19 of 30| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| First Aid Only | 59753 | FDA UDI | N | Active |
| First Aid Only | 520-FR | FDA UDI | N | Active |
| First Aid Only | 59702 | FDA UDI | N | Active |
| First Aid Only | FAE-6022 | FDA UDI | N | Active |
| First Aid Only | FAO-452 | FDA UDI | N | Active |
| First Aid Only | 59921 | FDA UDI | N | Active |
| First Aid Only | 710224 | FDA UDI | N | Active |
| First Aid Only | 613MC | FDA UDI | N | Active |
| First Aid Only | 3030FSI | FDA UDI | Class I | Active |
| First Aid Only | 59412 | FDA UDI | N | Active |
| First Aid Only | 59162 | FDA UDI | N | Active |
| First Aid Only | 746000 | FDA UDI | N | Active |
| First Aid Only | 5-6600 | FDA UDI | Class I | Active |
| First Aid Only | 59907 | FDA UDI | N | Active |
| First Aid Only | 991P | FDA UDI | N | Active |
| First Aid Only | 10097 | FDA UDI | N | Active |
| First Aid Only | 59632 | FDA UDI | N | Active |
| First Aid Only | 59187 | FDA UDI | N | Active |
| First Aid Only | 59170 | FDA UDI | N | Active |
| First Aid Only | 91296 | FDA UDI | N | Active |
| First Aid Only | 742185 | FDA UDI | N | Active |
| American Red Cross | 9161-RC | FDA UDI | N | Active |
| First Aid Only | 61TIX | FDA UDI | N | Active |
| First Aid Only | 54003 | FDA UDI | Class I | Active |
| First Aid Only | 59503 | FDA UDI | N | Active |
| First Aid Only | 54883 | FDA UDI | N | Active |
| First Aid Only | 711248 | FDA UDI | N | Active |
| First Aid Only | 54893 | FDA UDI | N | Active |
| First Aid Only | 90573 | FDA UDI | N | Active |
| First Aid Only | 59105 | FDA UDI | N | Active |
| First Aid Only | 91092 | FDA UDI | N | Active |
| First Aid Only | 90831 | FDA UDI | N | Active |
| First Aid Only | 21-2600 | FDA UDI | Class I | Active |
| First Aid Only | 742154 | FDA UDI | N | Active |
| American Red Cross | RC-600 | FDA UDI | N | Active |
| First Aid Only | 742035 | FDA UDI | N | Active |
| First Aid Only | 51007 | FDA UDI | Class I | Active |
| First Aid Only | 91110 | FDA UDI | N | Active |
| First Aid Only | 64TP36 | FDA UDI | N | Active |
| First Aid Only | 59278 | FDA UDI | N | Active |
| First Aid Only | 91023 | FDA UDI | Class I | Active |
| First Aid Only | FAO-442 | FDA UDI | N | Active |
| First Aid Only | 713000 | FDA UDI | N | Active |
| First Aid Only | 54948 | FDA UDI | N | Active |
| First Aid Only | 59664 | FDA UDI | N | Active |
| First Aid Only | 90936 | FDA UDI | N | Active |
| First Aid Only | 6405 | FDA UDI | Class I | Active |
| First Aid Only | FAE-6012 | FDA UDI | Class I | Active |
| First Aid Only | 742094 | FDA UDI | N | Active |
| First Aid Only | 1800CPR | FDA UDI | N | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.