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Sign in to claim this brandTransMedics, Inc
United States·US-MF-000029912
Last updated May 27, 2026
What TransMedics, Inc makes
TransMedics, Inc. manufactures systems and accessories for the preservation and transport of donor organs, including gas-refillable cylinders, perfusion initiation and termination sets, and connection kits for perfusion systems. Their portfolio also includes extracorporeal fluid flow probes, control units for organ preservation systems, data storage cards, and preservation solutions designed for organs and tissues. Battery packs for portable use are part of their product line to support mobile organ care applications.
The company’s devices are regulated under various classifications, including Class I, Class II, Class IIa, and Class III, depending on the product. Their systems are listed in regulatory databases such as EUDAMED, FDA’s 510(k), PMA, and UDI registries. The manufacturer is based in 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 TransMedics, Inc. primarily manufacture?
TransMedics, Inc. specializes in devices for donor-organ preservation and transport. Their portfolio includes systems like gas-refillable cylinders, perfusion initiation and termination sets, and connection kits for perfusion systems. They also produce extracorporeal fluid flow probes, control units for organ preservation systems, data storage cards, preservation solutions for organs and tissues, and portable rechargeable battery packs. These devices are designed to maintain organ viability during transport and storage.
Where is TransMedics, Inc. based, and how does this affect its regulatory oversight?
TransMedics, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including submissions to registries like the 510(k), PMA, and UDI databases. The U.S. regulatory framework governs the classification, clearance, and tracking of these devices, ensuring compliance with domestic and international standards for organ preservation and transport systems.
Which regulatory databases list TransMedics, Inc.’s devices, and why is this important?
TransMedics, Inc.’s devices are listed in key regulatory databases such as EUDAMED (for European market compliance), FDA’s 510(k), PMA (Premarket Approval), and UDI (Unique Device Identification) registries. Listing in these databases ensures transparency and traceability, allowing healthcare providers, regulators, and authorities to verify device details, compliance status, and safety information. This is critical for market authorization, post-market surveillance, and patient safety.
How are TransMedics, Inc.’s devices classified under regulatory frameworks?
TransMedics, Inc.’s devices fall under multiple regulatory classifications depending on their risk level and function. For example, simpler accessories like connection kits or data storage cards may be classified as Class I or Class II, while more complex systems like organ perfusion devices—such as the OCS Heart or Lung Systems—are often Class IIa or Class III due to their critical role in patient safety and life-support functions. Classification determines the regulatory pathway, including pre-market review requirements and post-market monitoring.
Why do some of TransMedics’ devices appear in multiple registries, such as both FDA and EUDAMED?
TransMedics’ devices appear in multiple registries because they are designed for global use, requiring compliance with both U.S. (FDA) and European (EUDAMED) regulatory standards. Listing in these databases ensures the devices meet the specific requirements of each market, such as FDA’s 510(k) or PMA for U.S. clearance and EUDAMED’s MDD/IVDR (Medical Device Directives/Regulations) for European authorization. This dual listing reflects the company’s focus on international distribution and adherence to diverse regulatory environments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 200, Minuteman Road, Andover, United States
- Website
- www.transmedics.com
- —
- —
- [email protected]
- Phone
- 978-552-0900
- PRRC Contact
- Christy Foreman
- EUDAMED SRN
- US-MF-000029912
- FDA FEI Number
- —
- DUNS Number
- 084445043
Catalogue (59)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OCS Heart System | 1000 | FDA UDI | Class III | Active |
| OCS Heart System | 1457 | FDA UDI | Class III | Active |
| Organ Care System | 1404 | FDA UDI | Class III | Active |
| OCS Lung System | 2200 | FDA UDI | Class III | Active |
| OCS Lung System | 2300 | FDA UDI | Class III | Active |
| OCS Liver System | 3406 | FDA UDI | Class III | Active |
| OCS Heart System | 1406 | FDA UDI | Class III | Active |
| OCS Heart System | 1427 | FDA UDI | Class III | Active |
| OCS Heart System | 1425 | FDA UDI | Class III | Active |
| OCS Liver System | 3440 | FDA UDI | Class III | Active |
| Organ Care System | 1426 | FDA UDI | Class III | Active |
| OCS Liver System | 3401 | FDA UDI | Class III | Active |
| Organ Care System | 1408 | FDA UDI | Class III | Active |
| OCS Heart System | 1300 | FDA UDI | Class III | Active |
| OCS Heart System | 1400 | FDA UDI | Class III | Active |
| OCS Heart System | 1424 | FDA UDI | Class III | Active |
| OCS Liver System | 3450 | FDA UDI | Class III | Active |
| Organ Care System | 1411 | FDA UDI | Class III | Active |
| OCS Heart System | 1410 | FDA UDI | Class III | Active |
| OCS Lung System | 2460 | FDA UDI | Class III | Active |
| OCS Liver System | 3421 | FDA UDI | Class III | Active |
| OCS Lung System | 2460 | FDA UDI | Class III | Active |
| OCS Lung System | 2401 | FDA UDI | Class III | Active |
| OCS Liver System | 3406 | FDA UDI | Class III | Active |
| OCS Liver System | 3457 | FDA UDI | Class III | Active |
| OCS Heart System | 1406 | FDA UDI | Class III | Active |
| OCS Liver System | 3400 | FDA UDI | Class III | Active |
| OCS Heart System | 1200 | FDA UDI | Class III | Active |
| Organ Care System | 2450 | FDA UDI | Class III | Active |
| OCS Heart System | 1421 | FDA UDI | Class III | Active |
| OCS Heart System | 1401 | FDA UDI | Class III | Active |
| OCS Heart System | 1461 | FDA UDI | Class III | Active |
| OCS Lung System | 2403 | FDA UDI | Class III | Active |
| OCS Lung System | 2464 | FDA UDI | Class III | Active |
| OCS Lung System | 2461 | FDA UDI | Class III | Active |
| Organ Care System | 1404 | FDA UDI | Class III | Active |
| OCS Lung System | 2461 | FDA UDI | Class III | Active |
| Organ Care System | 1408 | FDA UDI | Class III | Active |
| OCS Lung System | 2404 | FDA UDI | Class III | Active |
| Organ Care System | 1423 | FDA UDI | Class III | Active |
| OCS Lung Donor Flush Set | 2406 | FDA UDI | Class II | Active |
| Organ Care System | 1432 | FDA UDI | Class III | Active |
| OCS Lung System | 2402 | FDA UDI | Class III | Active |
| OCS Liver System | 3200 | FDA UDI | Class III | Active |
| OCS Class IIa Accessories/Components | 100004460 | EUDAMED | Class IIa | Active |
| OCS Accessories/Components | 1404, 1406, 1408, 1411, 1423, 1428, 1429, 1430, 1431, 1432, 1434, 1436, 2460, 2461, 2464, 1460 | EUDAMED | Class I | Active |
| OCS Heart Accessories | 1424, 1400, 1421, 1425, 1404, 1406, 1457, 1411, 1408, 1401, 1426, 1423, 1427, 1410, 1461, 1460, 1466, 1467 | EUDAMED | Class IIa | Active |
| OCS Lung Donor Flush Set | K222535 | FDA 510(k) | Class II | Active |
| Transmedica Model 100 Digital Electronic Stethoscope | K963418 | FDA 510(k) | Class II | Active |
| OCS Heart Leukocyte Depleting Filter | K231362 | FDA 510(k) | Class II | Active |
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