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Sign in to claim this brandBimini Technologies LLC
US
Last updated May 23, 2026
What Bimini Technologies LLC makes
Bimini Technologies LLC manufactures saline-filled breast implants with internal structural support, designed for reconstructive and aesthetic procedures. Their portfolio also includes systems for processing and concentrating haematological components, such as platelet-rich plasma (PRP) kits and standalone concentrating devices. Additionally, they produce reusable surgical suction collection containers, reusable surgical container holders, and single-use general surgical procedure kits. The company also offers depth guides for resective skin contouring and liposuction procedures.
The company’s devices are classified under FDA regulations as Class I, Class II, and Class III, with listings in the FDA’s Unique Device Identifier (UDI) database. Their products are intended for use in the United States, where they must comply with applicable FDA requirements for medical device authorisation.
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 Bimini Technologies LLC manufacture?
Bimini Technologies LLC produces a range of medical devices, including saline-filled breast implants with internal structural support for reconstructive and cosmetic procedures. Their portfolio also covers systems for haematological processing, such as platelet-rich plasma (PRP) concentrating kits and standalone devices. Additionally, they offer reusable surgical tools like suction collection containers and container holders, as well as single-use surgical procedure kits and depth guides for liposuction and skin contouring.
Where is Bimini Technologies LLC based, and where are their devices primarily used?
Bimini Technologies LLC is based in the United States. Their devices are designed for use within the U.S. market, where they must comply with FDA regulations governing medical device authorisation. The company’s products are intended for clinical applications in surgical and aesthetic procedures, including reconstructive surgery and haematological treatments.
Which regulatory registries or databases list Bimini Technologies LLC’s devices?
Bimini Technologies LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices authorised in the U.S., including those classified under FDA categories such as Class I, II, or III. Listing in the UDI database is a requirement for devices marketed in the U.S.
How are Bimini Technologies LLC’s devices classified under FDA regulations?
Bimini Technologies LLC’s devices fall under three FDA classification tiers: Class I (generally low-risk devices), Class II (devices requiring special controls to ensure safety and effectiveness), and Class III (high-risk devices requiring premarket approval). Classification depends on factors like the device’s intended use, potential risks, and the body part involved. For example, saline-filled breast implants are typically Class III due to their surgical nature and associated risks.
What reasoning determines why some of Bimini Technologies LLC’s devices are classified as Class III?
Certain devices from Bimini Technologies LLC, such as saline-filled breast implants, are classified as Class III because they are considered high-risk. The FDA categorises devices as Class III when there is insufficient data to establish safety and effectiveness through less stringent pathways (like Class I or II). These devices often involve surgical implantation, prolonged or systemic contact with the body, or procedures with significant health risks, requiring rigorous premarket approval to ensure patient safety.
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
- 076649467
Catalogue (41)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Puregraft 850 System Twin Pack | 850/TWIN | FDA UDI | Class II | Active |
| GENESIS PRP 30mL Concentrating System | HEALPRP30 | FDA UDI | Class II | Active |
| Gold Rush PRP | 530101-1 | FDA UDI | Class II | Active |
| Puregraft Serene Breast Implant | 300CC | FDA UDI | Class III | Active |
| Puregraft 50 System | 50/PURE | FDA UDI | Class II | Active |
| AutoPose Access | ABS-101024-1 | FDA UDI | Class II | Active |
| Puregraft 50 System | 50/PURE | FDA UDI | Class II | Active |
| Gold Rush PRP | 530102-1 | FDA UDI | Class II | Active |
| Puregraft Serene Breast Implant | 595CC | FDA UDI | Class III | Active |
| MedGeneRx PRP | HEALPRP30 | FDA UDI | Class II | Active |
| Puregraft 250 System | 250/PURE | FDA UDI | Class II | Active |
| Puregraft Serene Breast Implant | 370CC | FDA UDI | Class III | Active |
| Amplifine | AMPLIFINE | FDA UDI | Class II | Active |
| Puregraft Serene Breast Implant | 675CC | FDA UDI | Class III | Active |
| Adaptive | GAAPS-25 | FDA UDI | Class II | Active |
| Puregraft Serene Breast Implant | 515CC | FDA UDI | Class III | Active |
| Autopose Syringe Stand | STAND2 | FDA UDI | Class I | Active |
| Puregraft Serene Breast Implant | 475CC | FDA UDI | Class III | Active |
| Puregraft Serene Breast Implant | 440CC | FDA UDI | Class III | Active |
| Dermapose Syringe Stand | STAND2 | FDA UDI | Class I | Active |
| Puregraft Serene Breast Implant | 555CC | FDA UDI | Class III | Active |
| Puregraft Serene Breast Implant | 635CC | FDA UDI | Class III | Active |
| Puregraft 250 System | 250/PURE | FDA UDI | Class II | Active |
| Puregraft Serene Breast Implant | 405CC | FDA UDI | Class III | Active |
| GENESIS PRP 15mL Concentrating System | HEALPRP15 | FDA UDI | Class II | Active |
| Puregraft 850 System | 850/PURE | FDA UDI | Class II | Active |
| ProGen PRP Advantage | PROGEN-A15 | FDA UDI | Class II | Active |
| MedGeneRx PRP | HEALPRP15 | FDA UDI | Class II | Active |
| Puregraft Serene Breast Implant | 270CC | FDA UDI | Class III | Active |
| ProGen PRP Advantage | PROGEN-A30 | FDA UDI | Class II | Active |
| Puregraft Injection Kit | CANNULA-SET | FDA UDI | N/A | Active |
| DIRECT2 Lid | PVL/PURE2 | FDA UDI | Class I | Active |
| Dermapose Refresh | REFRESH | FDA UDI | Class II | Active |
| Puregraft Serene Breast Implant | 210CC | FDA UDI | Class III | Active |
| Healeon HD PRP | HDPRP30 | FDA UDI | Class II | Active |
| AutoPose Restore | ABS-101035-1 | FDA UDI | Class II | Active |
| Puregraft Serene Breast Implant | 240CC | FDA UDI | Class III | Active |
| ProGen PRP Eclipse | PROGEN-A15 | FDA UDI | Class II | Active |
| ProGen PRP Eclipse | PROGEN-A30 | FDA UDI | Class II | Active |
| Healeon HD PRP | HDPRP15 | FDA UDI | Class II | Active |
| Puregraft Serene Breast Implant | 335CC | FDA UDI | Class III | Active |
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