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Sign in to claim this brandEAKIN SURGICAL LIMITED
US
Last updated May 27, 2026
What EAKIN SURGICAL LIMITED makes
Eakin Surgical Limited manufactures single-use surgical instruments for irrigation, aspiration, and procedural applications. Their portfolio includes non-illuminating irrigation/aspiration cannulas, suction cannulas for surgical and emergency use, bone-coring punches, ENT foreign body extraction forceps, soft-tissue surgical hooks, body aspiration needles, and ENT surgical procedure kits without medication. These devices are designed for one-time use in clinical settings to support procedures in orthopedics, otolaryngology, and general surgery.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States, adhering to regulatory requirements for medical devices in that jurisdiction.
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 Eakin Surgical Limited manufacture?
Eakin Surgical Limited specializes in single-use surgical instruments primarily for irrigation, aspiration, and procedural applications. Their portfolio includes non-illuminating irrigation/aspiration cannulas, suction cannulas for surgical and emergency use, bone-coring punches, ENT (ear, nose, and throat) foreign body extraction forceps, soft-tissue surgical hooks, body aspiration needles, and ENT surgical procedure kits without medication. These devices are designed for one-time clinical use in specialties like orthopedics, otolaryngology, and general surgery.
Where is Eakin Surgical Limited based, and what regulatory jurisdiction does it operate under?
Eakin Surgical Limited is based in the United States. As a U.S.-based manufacturer, its devices must comply with FDA regulations, which govern the design, manufacturing, and distribution of medical devices in that jurisdiction. The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their registration and compliance with U.S. regulatory requirements.
Which regulatory registries or databases list Eakin Surgical Limited’s devices?
Eakin Surgical Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices throughout their distribution lifecycle, ensuring traceability and compliance with FDA regulations. This listing helps healthcare providers and regulators verify the identity and classification of the company’s products.
How are Eakin Surgical Limited’s devices classified under FDA regulations?
Eakin Surgical Limited’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and clinical context—such as whether it’s used in surgical irrigation, aspiration, or ENT procedures.
Why are Eakin Surgical Limited’s devices primarily single-use?
Eakin Surgical Limited’s devices are designed as single-use primarily to ensure patient safety, reduce infection risks, and maintain sterility in clinical settings. Single-use instruments eliminate the need for reprocessing, which can introduce contamination or damage if not done correctly. This design aligns with best practices in modern surgery, particularly for procedures involving irrigation, aspiration, or delicate tissue manipulation, where sterility and precision are critical.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- pelicanfh.co.uk
- —
- —
- [email protected]
- Phone
- +440292074740
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 239505063
Catalogue (221)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Single Use Professional | S104 | FDA UDI | Class II | Active |
| Single Use Professional | S184 | FDA UDI | Class II | Active |
| Single Use Professional | S193 | FDA UDI | Class II | Active |
| Single Use Surgical Professional | S009 | FDA UDI | Class II | Unknown |
| Single Use Professional | 7fgN140 | FDA UDI | Class II | Active |
| Single Use Professional | S086 | FDA UDI | Class II | Active |
| Single Use Professional | S024 | FDA UDI | Class II | Active |
| Single Use Professional | S213 | FDA UDI | Class I | Active |
| Single Use Professional | S010 | FDA UDI | Class II | Active |
| Single Use Professional | S465 | FDA UDI | Class II | Active |
| Single Use Professional | S436 | FDA UDI | Class II | Active |
| Single Use Professional | S093 | FDA UDI | Class II | Active |
| Single Use Professional | S147 | FDA UDI | Class II | Active |
| Single Use Professional | S161 | FDA UDI | Class I | Active |
| Single Use Professional | 8fgN140 | FDA UDI | Class II | Active |
| Single Use Professional | S447 | FDA UDI | Class II | Active |
| Single Use Professional | S456 | FDA UDI | Class II | Active |
| Single Use Professional | S455 | FDA UDI | Class II | Active |
| Single Use Professional | S087 | FDA UDI | Class II | Active |
| Single Use Professional | S190 | FDA UDI | Class II | Active |
| Single Use Professional | S321 | FDA UDI | Class II | Active |
| Single Use Professional | S380 | FDA UDI | Class I | Active |
| Single Use Professional | S214 | FDA UDI | Class I | Active |
| Single Use Professional | S168 | FDA UDI | Class II | Active |
| Single Use Professional | S471 | FDA UDI | Class II | Active |
| Single Use Professional | OPR003 | FDA UDI | Class II | Active |
| Single Use Professional | S460 | FDA UDI | Class II | Active |
| Single Use Professional | S076 | FDA UDI | Class II | Active |
| Single Use Professional | S458 | FDA UDI | Class II | Active |
| Single Use Professional | S099 | FDA UDI | Class II | Active |
| Single Use Professional | 10fgN100 | FDA UDI | Class II | Active |
| Single Use Professional | 6fgF140 | FDA UDI | Class II | Active |
| Single Use Professional | S101 | FDA UDI | Class II | Active |
| Single Use Professional | S390 | FDA UDI | Class II | Active |
| Single Use Professional | S138 | FDA UDI | Class I | Active |
| Single Use Professional | S439 | FDA UDI | Class II | Active |
| Single Use Surgical Professional | S164 | FDA UDI | Class II | Unknown |
| Single Use Surgical Professional | S081 | FDA UDI | Class I | Unknown |
| Single Use Professional | S096 | FDA UDI | Class II | Active |
| Single Use Professional | S189 | FDA UDI | Class II | Active |
| Single Use Professional | S192 | FDA UDI | Class II | Active |
| Single Use Surgical Professional | S441 | FDA UDI | Class II | Unknown |
| Single Use Professional | S019 | FDA UDI | Class I | Active |
| Single Use Professional | S185 | FDA UDI | Class II | Active |
| Single Use Professional | S177 | FDA UDI | Class II | Active |
| Single Use Professional | S343 | FDA UDI | Class II | Active |
| Single Use Surgical Professional | S368 | FDA UDI | Class I | Unknown |
| Single Use Professional | S072 | FDA UDI | Class II | Active |
| Single Use Surgical Professional | S218 | FDA UDI | Class I | Unknown |
| Single Use Surgical Professional | S211 | FDA UDI | Class I | Unknown |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Eakin Surgical Ltd CARDIFF · GB FEI 3004476158