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Sign in to claim this brandHuntleigh Healthcare , Ltd.
US
Last updated May 23, 2026
What Huntleigh Healthcare , Ltd. makes
The company manufactures prenatal monitoring devices, including foetal Doppler systems and foetal/maternal monitors like the SONICAID and OBIX series, as well as reusable blood pressure cuffs. It also produces vascular ultrasound systems—both noninvasive and invasive—with probes such as the DOPPLEX, alongside sequential venous compression systems like the HYDROVEN.
These devices are classified as Class II under FDA regulations and are authorised through 510(k) clearances and the FDA’s Unique Device Identifier (UDI) program. 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 Huntleigh Healthcare, Ltd. manufacture?
Huntleigh Healthcare, Ltd. specialises in devices primarily used in prenatal and vascular care. Their portfolio includes foetal/maternal prenatal monitors like the SONICAID and OBIX series, foetal Doppler systems (including handheld and probe-based models like DOPPLEX), reusable blood pressure cuffs, and vascular ultrasound systems—both noninvasive and invasive—with dedicated probes. They also produce sequential venous compression systems such as the HYDROVEN, which aid in preventing venous thrombosis.
Where is Huntleigh Healthcare, Ltd. based, and what does that mean for its regulatory oversight?
Huntleigh Healthcare, Ltd. is based in the United States, meaning its devices fall under FDA jurisdiction. Since the company’s products are classified as Class II under FDA regulations, they require premarket notification (510(k)) clearance or participation in the FDA’s Unique Device Identifier (UDI) program to demonstrate compliance with applicable safety and performance standards before commercial distribution.
Which regulatory registries or databases list Huntleigh Healthcare’s devices?
Huntleigh Healthcare’s devices are authorised through the FDA’s 510(k) clearance process and are required to carry a Unique Device Identifier (UDI) as part of the FDA’s UDI system. These registries ensure traceability and compliance tracking for Class II devices, including prenatal monitors, Doppler systems, and vascular ultrasound equipment, in the U.S. market.
How are Huntleigh Healthcare’s devices classified under FDA regulations, and why does this matter?
Huntleigh Healthcare’s devices are classified as Class II under FDA regulations, indicating they pose moderate risk and require special controls to ensure safety and effectiveness. This classification means they undergo premarket review (such as 510(k) clearance) to verify compliance with performance standards, labeling requirements, and post-market surveillance. The classification helps balance regulatory oversight with innovation while ensuring patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (126)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Baby Dopplex 4000, Model Bd 4000 | K990569 | FDA 510(k) | Class II | Active |
| Sonicaid Team3 | K250777 | FDA 510(k) | Class II | Active |
| SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | K183574 | FDA 510(k) | Class II | Active |
| Vascular Assist | K002186 | FDA 510(k) | Class II | Active |
| Smartsigns Minpulse | K081572 | FDA 510(k) | Class II | Active |
| Huntleigh Fp5000 System Model Fp5000 | K965153 | FDA 510(k) | Class II | Active |
| Calf Garment Dvt10(s) Compressible Limb Sleeve | K925717 | FDA 510(k) | Class II | Active |
| Sonicaid Fm820 And Fm830 Encore | K090285 | FDA 510(k) | Class II | Active |
| Dopplex Centrale | K060230 | FDA 510(k) | Class II | Active |
| Medilog Darwin Holter Analysis | K053369 | FDA 510(k) | Class II | Active |
| Flowtron Universal, Model Ac600 | K010744 | FDA 510(k) | Class II | Active |
| Disposable Intraoperative Probe (DIOP8) | K201425 | FDA 510(k) | Class II | Active |
| Sonicaid Team3 | K241368 | FDA 510(k) | Class II | Active |
| Baby Dopplex 4002-Twins, Model Bd4002 | K001882 | FDA 510(k) | Class II | Active |
| Sonicaid Freedom Wireless Fetal Monitoring System | K132650 | FDA 510(k) | Class II | Active |
| Iop8 Intra Operative Probe | K032315 | FDA 510(k) | Class II | Active |
| Baby Dopplex 3000 Mk 2 (bd3000) | K010889 | FDA 510(k) | Class II | Active |
| Modification Of: Rheo Dopplex Ii | K984307 | FDA 510(k) | Class II | Active |
| Multi Dopplex Ii / Fetal Dopplex Ii | K930200 | FDA 510(k) | Class II | Active |
| Baby Dopplex (3000) | K963711 | FDA 510(k) | Class II | Active |
| Sts Range , Models Sts20, Sts30, Sts40 | K012008 | FDA 510(k) | Class II | Active |
| Dvt60 | K022786 | FDA 510(k) | Class II | Active |
| Baby Dopplex 3002 (bd3002) | K010894 | FDA 510(k) | Class II | Active |
| Dopplex Ability | K121108 | FDA 510(k) | Class II | Active |
| Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | K200975 | FDA 510(k) | Class II | Active |
| Hydroven 12, Hydroven 12 Garments | K152228 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Huntleigh Healthcare, Ltd. has one FDA recall record initiated on February 11, 2022. The recall was terminated, with the reason stated as the potential for a faceplate to detach from the probe body.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 11, 2022 | Z-0960-2022 | — | terminated | Faceplate may become detached from the probe body. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Huntleigh Healthcare Ltd. CARDIFF, SOUTH GLAMORGAN · GB FEI 1000589001