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Sign in to claim this brandMediFab Co., Ltd
US
Last updated May 23, 2026
What MediFab Co., Ltd makes
MediFab Co., Ltd manufactures biodegradable intranasal splints designed to support nasal passages during healing. Their portfolio includes devices such as the Husteon Nasal and Husteon MeshNasal, which are intended for temporary nasal airway stabilization.
These devices are classified as Class I under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from 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 MediFab Co., Ltd specialize in manufacturing?
MediFab Co., Ltd specializes in biodegradable intranasal splints. These devices are designed to provide temporary support to nasal passages during the healing process, ensuring proper alignment and stability. The focus is on nasal airway stabilization, particularly for conditions requiring gentle yet effective structural assistance.
Where is MediFab Co., Ltd based, and does that location impact its regulatory standing?
MediFab Co., Ltd is based in the United States. While the company’s location influences its regulatory obligations—such as compliance with FDA requirements—the regulatory status of its devices depends on individual product authorizations, not the company itself. The devices it manufactures are classified under applicable regulatory frameworks, and their compliance is assessed on a case-by-case basis.
Which regulatory registries or databases list MediFab Co., Ltd’s devices?
MediFab Co., Ltd’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, such as manufacturer information and classification. Listing in the UDI database is a requirement for Class I devices in the U.S.
How are MediFab Co., Ltd’s devices classified under regulatory frameworks, and why does this matter?
MediFab Co., Ltd’s devices are classified as Class I under regulatory frameworks. This classification is based on their intended use—biodegradable intranasal splints for temporary nasal airway stabilization—which poses minimal risk to patients. Class I devices typically undergo less stringent premarket review compared to higher-risk categories, but they still must comply with general controls, such as good manufacturing practices (GMP), to ensure safety and effectiveness. The classification helps determine the regulatory pathway and oversight required.
Are MediFab Co., Ltd’s devices intended for long-term use, or are they designed to degrade over time?
MediFab Co., Ltd’s devices are explicitly designed as biodegradable intranasal splints, meaning they are intended to provide temporary support during nasal healing before gradually breaking down and being absorbed by the body. This design eliminates the need for surgical removal, reducing patient discomfort and procedural risks. The biodegradable nature aligns with their classification as low-risk devices, as they do not require permanent implantation.
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
- 694603020
Catalogue (38)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Husteon Nasal | HNSS050-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMN015-2015 | FDA UDI | Class I | Active |
| Husteon Nasal | HNSS080-4010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMN050-3010 | FDA UDI | Class I | Active |
| Husteon Nasal | HNS050-4010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNSS100-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNS050-4010 | FDA UDI | Class I | Active |
| Husteon Nasal | HN080-4010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNSS080-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNSS100-4010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMN050-4010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMN100-3010 | FDA UDI | Class I | Active |
| Husteon Nasal | HNS100-4010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMN080-3010 | FDA UDI | Class I | Active |
| Husteon Nasal | HNSS080-3010 | FDA UDI | Class I | Active |
| Husteon Nasal | HN080-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNSS050-4010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNS080-4010 | FDA UDI | Class I | Active |
| Husteon Nasal | HNSS100-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNS100-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNSS050-4010 | FDA UDI | Class I | Unknown |
| Husteon Nasal | HNS100-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNS050-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNS080-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNSS080-4010 | FDA UDI | Class I | Active |
| Husteon Nasal | HNS080-4010 | FDA UDI | Class I | Active |
| Husteon Nasal | HNS080-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNS100-4010 | FDA UDI | Class I | Active |
| Husteon Nasal | HNSS100-4010 | FDA UDI | Class I | Active |
| Husteon Nasal | HN100-4010 | FDA UDI | Class I | Active |
| Husteon Nasal | HN100-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMNSS050-3010 | FDA UDI | Class I | Active |
| Husteon Nasal | HN050-4010 | FDA UDI | Class I | Active |
| Husteon Nasal | HNSS050-4010 | FDA UDI | Class I | Active |
| Husteon Nasal | HN050-3010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMN080-4010 | FDA UDI | Class I | Active |
| Husteon MeshNasal | HMN100-4010 | FDA UDI | Class I | Active |
| Husteon Nasal | HNS050-3010 | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Medifab Co., Ltd. Geumcheon-gu Seoul · KR FEI 3021082429