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Sign in to claim this brandShanghai Kindly Enterprise Dev. Group Co.,
China·CN-MF-000005652
Last updated May 23, 2026
What Shanghai Kindly Enterprise Dev. Group Co., makes
The company manufactures KDL syringes and needles, designed for single-use medical injections and fluid administration.
These devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. 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 Shanghai Kindly Enterprise Dev. Group Co. manufacture?
Shanghai Kindly Enterprise Dev. Group Co. specializes in producing KDL syringes and needles, which are intended for single-use medical injections and fluid administration. These devices are engineered to meet common clinical needs in fluid delivery and injection therapies.
Where is Shanghai Kindly Enterprise Dev. Group Co. based?
The company is headquartered in the United States. This location allows it to align with U.S. regulatory standards and manufacturing practices for its medical devices.
How are the devices manufactured by Shanghai Kindly Enterprise Dev. Group Co. classified under FDA regulations?
The company’s KDL syringes and needles fall under Class II classification by the FDA. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Are the devices manufactured by Shanghai Kindly Enterprise Dev. Group Co. listed in any regulatory registries?
Yes, the company’s KDL syringes and needles are included in the FDA’s 510(k) clearance registry. This registry tracks devices that have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring compliance with FDA requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- 658, Gaochao Road, Shanghai, China
- Website
- www.kdlchina.com
- —
- —
- [email protected]
- Phone
- +8613818332762
- PRRC Contact
- Hualong Liu
- EUDAMED SRN
- CN-MF-000005652
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (59)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Terumo | SENG-03L2325R | FDA UDI | Class II | Active |
| Sterile Oral Syringes for single use | OSC10ML | EUDAMED | Class I | Active |
| Kdl Syringes And Needle | K112057 | FDA 510(k) | Class II | Active |
| Sterile Aesthetic Cannula and Hypodermic Needle | K223327 | FDA 510(k) | Class II | Active |
| Sterile Oral Syringes for single use | OSC1ML | EUDAMED | Class I | Active |
| nasal irrigator | NI-10 | EUDAMED | Class I | Active |
| Baby Nasal Irrigator | NA-01-A | EUDAMED | Class I | Active |
| Sterile Oral Syringes for single use | OASC3ML | EUDAMED | Class I | Active |
| Sterile Protective cap for single use | CP0202 | EUDAMED | Class I | Active |
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