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Sign in to claim this brand3-D Matrix Europe SAS
US
Last updated May 23, 2026
What 3-D Matrix Europe SAS makes
3-D Matrix Europe SAS manufactures synthetic peptide haemostatic agents designed to control bleeding in surgical procedures. Their primary product, PuraStat, is applied topically to promote rapid clotting at wound sites, particularly in high-risk or complex surgeries.
The company’s haemostatic agents are classified as Class II (under the EU MDR) and Class II/Unclassified (U) in the US, with submissions filed via 510(k) and UDI registrations. These products are listed in the FDA’s regulatory databases and are 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 3-D Matrix Europe SAS manufacture?
3-D Matrix Europe SAS specialises in synthetic peptide haemostatic agents. These products are designed to stop bleeding during surgical procedures by promoting rapid clotting when applied topically to wound sites. Their primary focus is on high-risk or complex surgeries where bleeding control is critical.
Where is 3-D Matrix Europe SAS based?
The company is based in the United States. This location influences its regulatory submissions, including compliance with US-specific requirements like 510(k) clearances and UDI registrations for its haemostatic agents.
Which regulatory registries list the devices made by 3-D Matrix Europe SAS?
The company’s devices, including its synthetic peptide haemostatic agents like PuraStat, are listed in the FDA’s 510(k) and UDI registries. These databases track devices that have undergone regulatory submissions in the US, ensuring transparency and compliance with US medical device regulations.
How are the devices manufactured by 3-D Matrix Europe SAS classified?
The haemostatic agents produced by 3-D Matrix Europe SAS fall under Class II classification in the EU MDR framework and are also classified as Class II or Unclassified (U) in the US. This classification reflects their moderate risk level, requiring specific regulatory oversight but not the highest scrutiny reserved for Class III devices.
AI-generated from registry data and not verified by a human reviewer.
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Catalogue (5)
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- 3-D Matrix Europe Sas Caluire et Cuire Rhone · FR FEI 3012263097