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Sign in to claim this brandNATURAL BREAST K.K.
US
Last updated May 25, 2026
What NATURAL BREAST K.K. makes
Natural Breast K.K. manufactures external breast prostheses and nipple prostheses designed for post-mastectomy or reconstructive use. These devices are intended to provide a natural appearance and fit for individuals requiring external coverage or contouring. The prostheses are available in various sizes and shapes to accommodate different body types and medical needs.
The company’s products fall under Class I medical devices, indicating a low to moderate risk profile. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory compliance. The manufacturer operates from the United States, adhering to applicable domestic and international standards for external prostheses.
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 Natural Breast K.K. manufacture?
Natural Breast K.K. specializes in external breast prostheses and nipple prostheses. These devices are designed for individuals who require external coverage or contouring, such as after mastectomy or reconstructive surgery. The prostheses are crafted to provide a natural appearance and fit, with options available in various sizes and shapes to suit different anatomical needs.
Where is Natural Breast K.K. based, and does its location affect its products?
Natural Breast K.K. is based in the United States. While the company’s location ensures compliance with U.S. regulatory standards, the primary focus is on designing and manufacturing external prostheses that meet global safety and performance expectations. The devices are classified under Class I, which reflects a low to moderate risk level, and are listed in the FDA’s UDI database for traceability.
Which regulatory registries or databases list Natural Breast K.K.’s devices?
Natural Breast K.K.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures that each device can be uniquely identified, tracked, and traced throughout its lifecycle, which is essential for regulatory compliance and patient safety. This listing helps healthcare providers and regulators verify the device’s identity and compliance status.
How are Natural Breast K.K.’s devices classified under medical device regulations?
Natural Breast K.K.’s external breast prostheses and nipple prostheses fall under Class I medical device classification. This classification is assigned based on the risk profile of the device—Class I devices are generally considered to pose low to moderate risk to patients. The classification helps determine the regulatory oversight required, though even Class I devices must meet specific safety and performance standards to ensure their intended use is achieved without undue risk.
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
- 692387886
Catalogue (37)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
| my breast | 1 | FDA UDI | Class I | Active |
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