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Sign in to claim this brandHunter Amenities (Shantou) Co., Ltd.
US
Last updated May 23, 2026
What Hunter Amenities (Shantou) Co., Ltd. makes
Hunter Amenities (Shantou) Co., Ltd. manufactures basic manual toothbrushes designed for use in hospitality settings, including branded and generic models for hotels such as Park Hyatt, Fairmont, Hyatt, St. Regis, and W Hotel. These toothbrushes are intended for guestroom amenities and are typically sold in bulk for distribution in luxury and mid-range accommodations.
The company’s products fall under FDA Class I medical devices and are listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer is based in the United States, adhering to regulatory requirements for Class I devices, which generally involve less stringent premarket review but still require compliance with applicable standards and labeling regulations.
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 Hunter Amenities (Shantou) Co., Ltd. manufacture?
Hunter Amenities (Shantou) Co., Ltd. specializes in basic manual toothbrushes. These devices are designed specifically for hospitality settings, such as hotels, and are often customized with branded labels for establishments like Park Hyatt, Fairmont, Hyatt, St. Regis, W Hotel, and others. The focus is on guestroom amenities, ensuring hygiene and convenience for hotel guests.
Where is Hunter Amenities (Shantou) Co., Ltd. based, and how does that affect its operations?
Hunter Amenities (Shantou) Co., Ltd. is based in the United States. As a U.S.-based manufacturer, the company must comply with FDA regulations applicable to its devices, including labeling, manufacturing practices, and registration requirements. The location also influences its ability to participate in domestic regulatory programs, such as the FDA’s Unique Device Identification (UDI) system.
Which regulatory registries or databases list Hunter Amenities (Shantou) Co., Ltd.’s devices?
Hunter Amenities (Shantou) Co., Ltd.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for Class I devices like manual toothbrushes. Listing in the UDI system is a requirement for compliance with FDA regulations.
How are Hunter Amenities (Shantou) Co., Ltd.’s devices classified under FDA regulations?
Hunter Amenities (Shantou) Co., Ltd.’s manual toothbrushes are classified as FDA Class I medical devices. Class I devices are generally considered low-risk and do not require premarket approval or a formal submission process before being marketed. However, they still must comply with FDA labeling requirements, manufacturing standards, and registration rules to ensure safety and proper use.
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
- 554538623
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Generic Hotel | 50916000001 | FDA UDI | Class I | Active |
| Park Hyatt NYC | 51316000002 | FDA UDI | Class I | Active |
| Fairmont Le Labo | 50916000013 | FDA UDI | Class I | Active |
| Hyatt(CPE) | 50916000007 | FDA UDI | Class I | Active |
| Baha Mar | 50916000018 | FDA UDI | Class I | Active |
| Edition | 50916000029 | FDA UDI | Class I | Active |
| Fairmont Hotel | 50916000005 | FDA UDI | Class I | Active |
| Park Hyatt NYC | 51316000001 | FDA UDI | Class I | Active |
| MiN New York | 50916000031 | FDA UDI | Class I | Active |
| St.Regis | 50916000003 | FDA UDI | Class I | Active |
| Edition Hotel | 50916000019 | FDA UDI | Class I | Active |
| W Hotel | 50916000004 | 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.
- Hunter Amenities (Shantou) Co., Ltd. - Guangdong · CN FEI 3009410543