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Sign in to claim this brandCOPAN ITALIA SPA
US
Last updated May 23, 2026
What COPAN ITALIA SPA makes
COPAN Italia SpA manufactures single-use medical devices for specimen collection, transport, and storage, including general-purpose swabs (e.g., FLOQSwabs®, CLASSIQSwabs®), rectal/faecal collection kits (e.g., TransPorter®), non-evacuated urine containers (e.g., UriFree), and evacuated blood collection tubes (e.g., BBL™ CultureSwab™ Plus). Their portfolio also includes inoculating tools, specimen transfer scoops, and preservative-containing containers (e.g., UTM®, UTM-RT) designed for microbiological and diagnostic testing.
These devices are classified under FDA regulations as Class I or Class II, with some authorised via the 510(k) pathway and others listed under the UDI system. The company’s products are registered for use in the United States, adhering to FDA compliance requirements for in vitro diagnostics (IVD) and general medical devices.
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 COPAN Italia SpA manufacture?
COPAN Italia SpA specialises in single-use medical devices primarily for specimen collection, transport, and storage. Their portfolio includes general-purpose swabs like FLOQSwabs® and CLASSIQSwabs®, rectal/faecal collection kits such as TransPorter®, non-evacuated urine containers like UriFree, and evacuated blood collection tubes like BBL™ CultureSwab™ Plus. They also produce inoculating tools, specimen transfer scoops, and preservative-containing containers (e.g., UTM®, UTM-RT) tailored for microbiological and diagnostic testing.
Where is COPAN Italia SpA based, and what does that mean for their regulatory compliance?
COPAN Italia SpA is based in the United States, which means their devices must comply with FDA regulations. Since their products fall under categories like in vitro diagnostics (IVD) and general medical devices, they are authorised through pathways like the 510(k) clearance or the UDI system, depending on the classification. The FDA’s jurisdiction ensures their devices meet U.S. safety, performance, and labelling standards.
Which regulatory registries or databases list COPAN Italia SpA’s devices?
COPAN Italia SpA’s devices are registered in the FDA’s 510(k) premarket notification database for certain Class II products, as well as the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability, compliance tracking, and transparency for authorised medical devices in the U.S. market.
How are COPAN Italia SpA’s devices classified under FDA regulations?
COPAN Italia SpA’s devices are classified as either Class I (generally low-risk, with minimal regulatory controls) or Class II (moderate-risk, requiring special controls to ensure safety and effectiveness). For example, general swabs or specimen containers may fall under Class I, while more complex devices like certain preservative-containing containers or inoculating tools may be Class II. The classification determines whether they require a 510(k) clearance or are listed under the UDI system.
Are COPAN Italia SpA’s devices used for microbiological or diagnostic testing?
Yes, many of COPAN Italia SpA’s devices are designed specifically for microbiological and diagnostic testing. Products like FLOQSwabs® (for sample collection), UTM® (preservative-containing transport media), and TransPorter® (for faecal/rectal specimens) are engineered to preserve sample integrity during transport and storage, ensuring reliable results in laboratory testing. Their devices are authorised for use in clinical diagnostics, including infectious disease testing.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 428981112
Catalogue (264)
Page 4 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CultureSwab™ MaxV(+) | 220236 | FDA UDI | Class I | Active |
| Transystem™ | 140CQ | FDA UDI | Class I | Active |
| Transystem™ | 114C.USE | FDA UDI | Class I | Active |
| TransPorter® | 4138 | FDA UDI | Class I | Active |
| Transystem™ | 125C.USE | FDA UDI | Class I | Active |
| TransPorter® | 4019 | FDA UDI | Class I | Active |
| CLASSIQSwabs™ | 175KS01.US | FDA UDI | Class I | Active |
| FLOQSwabs® | 516CS01 | FDA UDI | Class I | Active |
| CLASSIQSwabs™ | 167KS01 | FDA UDI | Class I | Active |
| BBL™ CultureSwab™ Plus | 220119 | FDA UDI | Class I | Active |
| FLOQSwabs® | 551C | FDA UDI | Class I | Active |
| TransPorter® | 4124 | FDA UDI | Class I | Active |
| FLOQSwabs® | 501CS01 | FDA UDI | Class I | Active |
| Utm® | 360C | FDA UDI | Class I | Active |
| Transystem™ | 136C.USE | FDA UDI | Class I | Active |
| FLOQSwabs® | 50U003DS | FDA UDI | Class I | Active |
| TransPorter® | 4108 | FDA UDI | Class I | Active |
| FLOQSwabs® | 501CS01.Q20 | FDA UDI | Class I | Active |
| CLASSIQSwabs™ | 170KS01.US | FDA UDI | Class I | Active |
| CLASSIQSwabs™ | 184CS01 | FDA UDI | Class I | Active |
| FLOQSwabs® hDNA Free | 50U008DS01 | FDA UDI | Class I | Active |
| FLOQSwabs® | 220250 | FDA UDI | Class I | Active |
| LBM® UriSponge™ | 8C020S100.A | FDA UDI | Class I | Active |
| FLOQSwabs® | 220252 | FDA UDI | Class I | Active |
| UriSponge™ | 8U033S50 | FDA UDI | Class I | Active |
| BBL™ CultureSwab™ Plus | 220118 | FDA UDI | Class I | Active |
| FLOQSwabs® | 520C | FDA UDI | Class I | Active |
| LBM CABroth | 4U161N | EUDAMEDFDA UDI | Class I | Active |
| FLOQBrush™ | 5E007S01 | FDA UDI | Class I | Active |
| Utm® | 3C100N01 | FDA UDI | Class I | Active |
| FLOQSwabs® | 503CS01 | FDA UDI | Class I | Active |
| LBM® Selenite | 475CE.A | FDA UDI | Class I | Active |
| Bhi Broth | 474CE.A | FDA UDI | Class I | Active |
| FLOQSwabs® | 808821 | FDA UDI | Class I | Active |
| FLOQSwabs® | 553C.LC | FDA UDI | Class I | Active |
| BD Universal Viral Transport | 220221 | FDA UDI | Class I | Active |
| BBL™ CultureSwab™ | 220135 | FDA UDI | Class I | Active |
| Utm-Rt | 3C038N.HL | FDA UDI | Class I | Active |
| FLOQSwabs® | 5U092S | FDA UDI | Class I | Active |
| Utm® | 359C | FDA UDI | Class I | Active |
| LIM Broth | 476CE.A | FDA UDI | Class I | Active |
| Copan Universal Transport Medium (UTM-RT) System | 3C064N | FDA UDI | Class I | Active |
| Inoculation Needles | 176CS20 | FDA UDI | Class I | Active |
| CLASSIQSwabs™ | 1U054S01 | FDA UDI | Class I | Active |
| FLOQSwabs® | 518C | FDA UDI | Class I | Active |
| FLOQSwabs® | 552C | FDA UDI | Class I | Active |
| Inoculation Loops | 179CSR40 | FDA UDI | Class I | Active |
| Transystem™ | 132C.USE | FDA UDI | Class I | Active |
| CLASSIQSwabs™ | 167KS01.US | FDA UDI | Class I | Active |
| CLASSIQSwabs™ | 175KS01 | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Copan Italia BRESCIA Lombardy · IT FEI 3002444944