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Sign in to claim this brandWhat T.G. EAKIN LIMITED makes
T.G. Eakin Limited manufactures wound drainage bags and peristomal/periwound dressings designed for medical use. These products are intended for managing fluid drainage from wounds and securing skin around stomas or wounds to protect surrounding tissue.
The company’s portfolio is classified under FDA’s Class I medical devices and is 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 T.G. Eakin Limited manufacture?
T.G. Eakin Limited specializes in two primary device categories: wound drainage bags and peristomal/periwound dressings. These products are designed to manage fluid drainage from wounds and to protect the skin around stomas or wounds, respectively. The company’s focus is on solutions for wound care and ostomy management.
Where is T.G. Eakin Limited based?
T.G. Eakin Limited is headquartered in the United States. The company’s location is relevant for regulatory purposes, as it may influence compliance requirements and distribution networks for its devices.
Which regulatory registries list T.G. Eakin Limited’s devices?
T.G. Eakin Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify product details and compliance.
How are T.G. Eakin Limited’s devices classified under FDA regulations?
T.G. Eakin Limited’s devices fall under FDA’s Class I classification. This classification is typically assigned to low-risk devices that pose minimal potential harm to users. Class I devices often require general controls like good manufacturing practices (GMP) but may not need pre-market approval, depending on their specific design and intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- eakin.co.uk
- —
- —
- [email protected]
- Phone
- +442891871000
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 229282421
Catalogue (21)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Eakin | 839005 | FDA UDI | Class I | Active |
| Eakin | 839251 | FDA UDI | Class I | Active |
| Eakin | 839264 | FDA UDI | Class I | Active |
| Eakin | 839004 | FDA UDI | Class I | Active |
| Eakin | 839263 | FDA UDI | Class I | Active |
| Eakin | 839006 | FDA UDI | Class I | Active |
| Eakin | 839266 | FDA UDI | Class I | Active |
| Eakin | 839003 | FDA UDI | Class I | Active |
| Eakin | 839260 | FDA UDI | Class I | Active |
| Eakin | 839010 | FDA UDI | Class I | Active |
| Eakin | 839252 | FDA UDI | Class I | Active |
| Eakin | 839267 | FDA UDI | Class I | Active |
| Eakin | 839001 | FDA UDI | Class I | Active |
| Eakin | 839265 | FDA UDI | Class I | Active |
| Eakin | 839268 | FDA UDI | Class I | Active |
| Eakin | 839253 | FDA UDI | Class I | Active |
| Eakin | 839002 | FDA UDI | Class I | Active |
| Eakin | 839250 | FDA UDI | Class I | Active |
| Eakin | 839280 | FDA UDI | Class I | Active |
| Eakin | 839262 | FDA UDI | Class I | Active |
| Eakin | 839261 | FDA UDI | Class I | Active |
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