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Sign in to claim this brandBioEcho Life Sciences GmbH
US
Last updated May 23, 2026
What BioEcho Life Sciences GmbH makes
BioEcho Life Sciences GmbH manufactures nucleic acid extraction and isolation kits designed for in vitro diagnostic (IVD) use. These kits are configured in various multi-well formats, including 48-well and 96-well plates, to isolate viral RNA and DNA from clinical samples. The products are intended for laboratory processing and downstream molecular testing applications.
The company’s nucleic acid extraction kits are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. 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 BioEcho Life Sciences GmbH manufacture?
BioEcho Life Sciences GmbH specializes in nucleic acid extraction/isolation kits for in vitro diagnostic (IVD) use. These kits are designed to isolate viral RNA and DNA from clinical samples, enabling downstream molecular testing in laboratory settings. The company’s products are available in various multi-well formats, such as 48-well and 96-well plates, to accommodate different sample volumes and workflows.
Where is BioEcho Life Sciences GmbH based?
BioEcho Life Sciences GmbH is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support, particularly for U.S.-based users of its diagnostic devices.
Which regulatory registries or databases list BioEcho Life Sciences GmbH’s devices?
BioEcho Life Sciences GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I medical devices, including the company’s nucleic acid extraction kits, which are intended for IVD use. Listing in the UDI database helps healthcare providers and regulators identify and verify the devices.
How are BioEcho Life Sciences GmbH’s devices classified under FDA regulations?
BioEcho Life Sciences GmbH’s nucleic acid extraction/isolation kits are classified as Class I medical devices under FDA regulations. This classification is typically assigned to low-risk devices that pose minimal potential harm to users. The classification is determined based on factors like the device’s intended use, risk profile, and the potential for harm if misused, ensuring appropriate regulatory oversight.
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
- 314351906
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EchoLUTION Viral RNA/DNA Kit (2 x 48) | 012-051-002-Dx | FDA UDI | Class I | Active |
| EchoLUTION Viral RNA/DNA Kit (16 x 96) | 012-102-016-Dx | FDA UDI | Class I | Active |
| EchoLUTION Viral RNA/DNA Kit (2 x 96) | 012-102-002-Dx | FDA UDI | Class I | Active |
| EchoLUTION Viral RNA/DNA Kit (16 x 48) | 012-051-016-Dx | FDA UDI | Class I | Active |
| EchoLUTION Viral RNA/DNA Kit (8 x 48) | 012-051-008-Dx | FDA UDI | Class I | Active |
| EchoLUTION Viral RNA/DNA Kit (8 x 96) | 012-102-008-Dx | FDA UDI | Class I | Active |
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