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Sign in to claim this brandBIOLIFE, L.L.C.
US
Last updated May 27, 2026
What BIOLIFE, L.L.C. makes
The company produces non-organic haemostatic agents designed to control bleeding in surgical and trauma settings. Its portfolio includes topical agents like WoundSeal®, which are applied directly to wounds, and StatSeal®, intended for rapid haemostasis in emergency procedures.
These products are classified as Class II (U) devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 Biolife, L.L.C. manufacture?
Biolife, L.L.C. specializes in non-organic haemostatic agents, which are medical devices designed to stop bleeding in surgical and trauma situations. These products are typically applied directly to wounds or used in emergency procedures to achieve rapid haemostasis. Examples include topical agents like WoundSeal® and StatSeal®, which are tailored for different clinical needs.
Where is Biolife, L.L.C. based, and what does this mean for its regulatory oversight?
Biolife, L.L.C. is based in the United States, which means its devices are subject to FDA regulations. The company’s products fall under the jurisdiction of the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device standards. This regulatory framework applies to individual devices, not the company itself.
How are Biolife, L.L.C.’s devices classified under FDA regulations?
Biolife, L.L.C.’s haemostatic agents, such as WoundSeal® and StatSeal®, are classified as Class II (U) devices by the FDA. This classification indicates they pose moderate risk and require special controls to ensure their safety and effectiveness, including performance standards and post-market surveillance, without requiring a premarket approval application.
Which regulatory registries or databases list Biolife, L.L.C.’s devices?
Biolife, L.L.C.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency and traceability of medical devices by assigning a unique identifier to each product, helping healthcare providers and regulators track and verify device information for compliance and safety purposes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- biolife.com
- —
- —
- [email protected]
- Phone
- +1 941.360.1300
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 135872476
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| WoundSeal® | WSO310ZC | FDA UDI | U | Active |
| WoundSeal® | QSO010ZC | FDA UDI | U | Active |
| WoundSeal® | WSO001Z | FDA UDI | U | Active |
| WoundSeal® | WSO310GC | FDA UDI | U | Active |
| WoundSeal® | NCW001 | FDA UDI | U | Active |
| WoundSeal® | NPS001 | FDA UDI | U | Active |
| WoundSeal® | DWS001 | FDA UDI | U | Unknown |
| WoundSeal® | WSO001GC | FDA UDI | U | Active |
| WoundSeal® | WSO310C | FDA UDI | U | Active |
| StatSeal® | DM015 | FDA UDI | U | Active |
| AV-Seal® | DIAL001 | FDA UDI | U | Unknown |
| WoundSeal® | CSU004 | FDA UDI | U | Active |
| StatSeal® | DE021 | FDA UDI | U | Unknown |
| StatSeal® | DT013 | FDA UDI | U | Active |
| WoundSeal® | QSO010GC | FDA UDI | U | Active |
| WoundSeal® | QSO020C | FDA UDI | U | Active |
| WoundSeal® | WSO001 | FDA UDI | U | Active |
| WoundSeal® | WSO310 | FDA UDI | U | Active |
| WoundSeal® | QSO010 | FDA UDI | U | Active |
| WoundSeal® | WSO1001C | FDA UDI | U | Active |
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