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Sign in to claim this brandShanghai Gangkai Purifying Products Co., Ltd.
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Last updated May 25, 2026
What Shanghai Gangkai Purifying Products Co., Ltd. makes
Shanghai Gangkai Purifying Products Co., Ltd. manufactures single-use, non-antimicrobial surgical and medical respirators designed to filter airborne particulates. Their products include models like the SHANGHAI GANGHAI MODEL GIKO 1400, intended for clinical and procedural use where filtered breathing protection is required.
The company’s respirators are classified as Class II devices under regulatory frameworks, with submissions listed via FDA’s 510(k) and UDI programs. The manufacturer operates from the United States, adhering to applicable medical device compliance standards for respiratory protection equipment.
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 Shanghai Gangkai Purifying Products Co., Ltd. manufacture?
Shanghai Gangkai Purifying Products Co., Ltd. specializes in surgical and medical respirators that are single-use and non-antimicrobial. These devices are designed to filter airborne particulates, ensuring filtered breathing protection during clinical and procedural settings. Examples include the Particulate Respirator and the SHANGHAI GANGHAI MODEL GIKO 1400.
Where is Shanghai Gangkai Purifying Products Co., Ltd. based?
The company is based in the United States. This location ensures compliance with U.S. regulatory standards for medical devices, including those related to respiratory protection equipment.
Which regulatory registries list devices manufactured by Shanghai Gangkai Purifying Products Co., Ltd.?
Devices from Shanghai Gangkai Purifying Products Co., Ltd. are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. These submissions reflect compliance with U.S. regulatory requirements for medical devices, particularly those classified under Class II.
How are devices from Shanghai Gangkai Purifying Products Co., Ltd. classified under regulatory frameworks?
The company’s respirators fall under Class II device classification, which typically indicates moderate risk and requires specific regulatory oversight. This classification ensures that the devices meet stringent performance and safety standards before being authorized for 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
- 653746735
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Particulate Respirator | GIKO 1400 | FDA UDI | Class II | Active |
| Shanghai Ganghai Model Giko 1400 | K063334 | 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.
- Shanghai Gangkai Purifying Products Co., Ltd. Songjiang Shanghai · CN FEI 3004168184