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Sign in to claim this brandChangzhou Holymed Products Co., Ltd.
US
Last updated May 25, 2026
What Changzhou Holymed Products Co., Ltd. makes
The company manufactures single-use professional examination gowns and intravenous line stopcocks, designed for clinical and procedural use in healthcare settings.
These products are regulated under FDA Class I and Class II categories, with records maintained in the FDA’s 510(k) and UDI databases. The company 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 Changzhou Holymed Products Co., Ltd. manufacture?
Changzhou Holymed Products Co., Ltd. specializes in two primary device categories: single-use professional examination gowns and intravenous line stopcocks. These products are designed for clinical and procedural use in healthcare environments, ensuring hygiene and functionality during patient examinations or treatments.
Where is Changzhou Holymed Products Co., Ltd. based?
The company is based in the United States. This location allows it to comply with U.S. regulatory standards for medical devices, including those governed by the FDA.
Which regulatory registries list devices manufactured by Changzhou Holymed Products Co., Ltd.?
Devices from Changzhou Holymed Products Co., Ltd. are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track device classifications and compliance records for Class I and Class II devices.
How are the devices produced by Changzhou Holymed Products Co., Ltd. classified under FDA regulations?
The company’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The specific classification depends on the device’s intended use and potential risks.
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
- 559978934
Catalogue (31)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Holymed | HLS3650EG2XL | FDA UDI | Class I | Active |
| Holymed | HLS3650EGL | FDA UDI | Class I | Active |
| Holymed | HLS3650EGS | FDA UDI | Class I | Active |
| Holymed | HL3660WH2XL | FDA UDI | Class I | Active |
| Holymed | HL3660SBL | FDA UDI | Class I | Active |
| Holymed | HL3660WHM | FDA UDI | Class I | Active |
| Holymed | HL3660WH5XL | FDA UDI | Class I | Active |
| Holymed | HLS3660WHXL | FDA UDI | Class I | Active |
| Holymed | HL3660SBXL | FDA UDI | Class I | Active |
| Holymed | HL3660SBXS | FDA UDI | Class I | Active |
| Holymed | HL3660WH3XL | FDA UDI | Class I | Active |
| Holymed | HL3660SB2XL | FDA UDI | Class I | Active |
| Holymed | HLS3650EGXS | FDA UDI | Class I | Active |
| Holymed | HL3660SB3XL | FDA UDI | Class I | Active |
| Holymed | HL3660SBS | FDA UDI | Class I | Active |
| Holymed | HL3660WHS | FDA UDI | Class I | Active |
| Holymed | HL3660SBM | FDA UDI | Class I | Active |
| Holymed | HLS3650EG5XL | FDA UDI | Class I | Active |
| Holymed | HL3660WHL | FDA UDI | Class I | Active |
| Holymed | HLS3650EG4XL | FDA UDI | Class I | Active |
| Holymed | HL3660SB4XL | FDA UDI | Class I | Active |
| Holymed | HLS3650EGM | FDA UDI | Class I | Active |
| Holymed | HL3660WHXL | FDA UDI | Class I | Active |
| Holymed | HL3660SB5XL | FDA UDI | Class I | Active |
| Holymed | HLS3650EGXL | FDA UDI | Class I | Active |
| Holymed | HL3660WHXS | FDA UDI | Class I | Active |
| Holymed | HL3660WH4XL | FDA UDI | Class I | Active |
| Holymed | HLS3650EG3XL | FDA UDI | Class I | Active |
| Hm Surgical Drapes Hm Surgical Equipment Cover | K122000 | FDA 510(k) | Class II | Active |
| Hm Surgical Gown, Non Reinforced Hm Surgical Gown, Fabric Reinforced Hm Surgical Gown, Polyerinforced | K121998 | FDA 510(k) | Class II | Active |
| Surgical Mask | K210524 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Changzhou Holymed Products Co., Ltd CHANGZHOU Jiangsu · CN FEI 3006891803