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Sign in to claim this brandCalico Medical Group LLC
US
Last updated May 30, 2026
What Calico Medical Group LLC makes
Calico Medical Group LLC produces single-use protective apparel and wound care dressings, including nitrile and latex examination gloves, isolation gowns, and surgical gowns. Their portfolio also covers exudate-absorbent dressings, both antimicrobial and non-antimicrobial variants, as well as cavity-wound management dressings with antimicrobial properties.
The company’s products are regulated under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer 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 Calico Medical Group LLC manufacture?
Calico Medical Group LLC specializes in single-use medical devices primarily focused on infection control and wound care. Their product range includes nitrile and latex examination gloves (non-powdered, non-antimicrobial), isolation gowns, surgical gowns, and various exudate-absorbent dressings. These dressings come in both antimicrobial and non-antimicrobial forms, with some designed specifically for cavity-wound management. The company’s portfolio is centered on protective apparel and dressings that help prevent contamination and promote wound healing.
Where is Calico Medical Group LLC based, and how does that affect its regulatory oversight?
Calico Medical Group LLC is based in the United States. Since the company operates within the U.S., its devices fall under the jurisdiction of the FDA. The FDA classifies their products into Class I, Class II, and Unclassified (U) categories, which determines the level of regulatory scrutiny and requirements for compliance. The U.S. regulatory framework ensures that these devices meet safety, performance, and labeling standards before entering the market.
Are Calico Medical Group LLC’s devices listed in any regulatory registries, and why does this matter?
Yes, Calico Medical Group LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry assigns a standardized identifier to each device, improving traceability, reducing medical errors, and facilitating better post-market surveillance. Listing in the UDI database ensures transparency and helps healthcare providers, regulators, and manufacturers track devices throughout their lifecycle, which is critical for compliance and patient safety.
How are Calico Medical Group LLC’s devices classified by the FDA, and what does that classification mean?
Calico Medical Group LLC’s devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories. Class I devices generally pose the lowest risk and typically require general controls (e.g., good manufacturing practices) for compliance. Class II devices involve moderate risk and may require additional performance standards or post-market surveillance. Unclassified (U) devices are those that do not yet have a classification assigned but are evaluated on a case-by-case basis. The classification determines the regulatory pathway and requirements for device authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- calicomed.com
- —
- —
- [email protected]
- Phone
- 619-454-1048
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 118744421
Catalogue (81)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Calico | CAD004 | FDA UDI | U | Active |
| Calico | FD016 | FDA UDI | Class I | Active |
| Calico | FD004 | FDA UDI | Class I | Active |
| Calico | NG009L | FDA UDI | Class I | Active |
| Calico | LG008 | FDA UDI | Class I | Active |
| Calico | SP001 | FDA UDI | U | Active |
| Calico | SG005 | FDA UDI | Class II | Active |
| Calico | FD015 | FDA UDI | Class I | Active |
| Calico | NG013M | FDA UDI | Class I | Active |
| Calico | NG022 | FDA UDI | Class I | Active |
| Calico | NG018 | FDA UDI | Class I | Active |
| Calico | NG006XS | FDA UDI | Class I | Active |
| Calico | STNG001M | FDA UDI | Class I | Active |
| Calico | SC00272 | FDA UDI | Class I | Active |
| Calico | GZ001 | FDA UDI | U | Active |
| Calico | SM002 | FDA UDI | Class II | Active |
| Calico | CAD005 | FDA UDI | U | Active |
| Calico | FD007 | FDA UDI | U | Active |
| Calico | SG002 | FDA UDI | Class II | Active |
| Calico | LG003M | FDA UDI | Class I | Active |
| Calico | NG001XS | FDA UDI | Class I | Active |
| Calico | NG011XS | FDA UDI | Class I | Active |
| Calico | FD001 | FDA UDI | Class I | Active |
| Calico | LG006 | FDA UDI | Class I | Active |
| Calico | SC00124 | FDA UDI | Class I | Active |
| Calico | NG010XL | FDA UDI | Class I | Active |
| Calico | FD011 | FDA UDI | Class I | Active |
| Calico | FD019 | FDA UDI | Class I | Active |
| Calico | LG004L | FDA UDI | Class I | Active |
| Calico | SG004 | FDA UDI | Class II | Active |
| Calico | FD006 | FDA UDI | Class I | Active |
| Calico | FD012 | FDA UDI | Class I | Active |
| Calico | FD018 | FDA UDI | Class I | Active |
| Calico | KSNG001 | FDA UDI | Class I | Active |
| Calico | FD009 | FDA UDI | U | Active |
| Calico | SG008 | FDA UDI | Class II | Active |
| Calico | SG007 | FDA UDI | Class II | Active |
| Calico | NG012S | FDA UDI | Class I | Active |
| Calico | ITNG001M | FDA UDI | Class I | Active |
| Calico | NG024 | FDA UDI | Class I | Active |
| Calico | NG020 | FDA UDI | Class I | Active |
| Calico | FD005 | FDA UDI | Class I | Active |
| Calico | NG023 | FDA UDI | Class I | Active |
| Calico | CAD006 | FDA UDI | U | Active |
| Calico | LG001XS | FDA UDI | Class I | Active |
| Calico | NG015XL | FDA UDI | Class I | Active |
| Calico | LG010 | FDA UDI | Class I | Active |
| Calico | NG021 | FDA UDI | Class I | Active |
| Calico | SM001 | FDA UDI | Class II | Active |
| Calico | LG009 | FDA UDI | Class I | Active |
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