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Shanghai 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +8613818332762
PRRC Contact: Hualong Liu
EUDAMED SRN: CN-MF-000005652
FDA FEI Number: —
DUNS Number: —

Catalogue (59)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Sterile Injection kits for single use	MCW227020	EUDAMED	Class IIa	Active
Sterile Safe Syringes for single use	SSK25G16MM	EUDAMED	Class IIa	Active
Sterile Zero residual small volume syringe without needle for single use	ZSR11102PC	EUDAMED	Class I	Active
Sterile Enteral syringes for single use	58078000050200	EUDAMED	Class I	Active
Sterile Injection kits for single use	MCW255023	EUDAMED	Class IIa	Active
Sterile Zero residual small volume syringe without needle for single use	ZSR11102	EUDAMED	Class I	Active
Sterile Injection kits for single use	MCW275025	EUDAMED	Class IIa	Active
Sterile Injection kits for single use	MCW225020	EUDAMED	Class IIa	Active
Sterile Safe Syringes for single use	SSK25G16MM	EUDAMED	Class IIa	Active
Sterile Enteral syringes for single use	58077000060100	EUDAMED	Class I	Active
Sterile Fluid transfer set for single use	TSP0301	EUDAMED	Class I	Active
Sterile Zero residual small volume syringe without needle for single use	ZSR11102C	EUDAMED	Class I	Active
Sterile Enteral syringes for single use	58075000050100	EUDAMED	Class I	Active
Sterile Zero residual small volume syringe without needle for single use	ZSR11202	EUDAMED	Class I	Active
Sterile Enteral syringes for single use	58076000050100	EUDAMED	Class I	Active
Reusable oral syringe	OSR101(RE)	EUDAMED	Class I	Active
Reusable Enteral Syringe	ESR201(RE)	EUDAMED	Class I	Active
Sterile Enteral syringes for single use	58078000060200	EUDAMED	Class I	Active
Sterile Zero residual small volume syringe without needle for single use	ZSR11103	EUDAMED	Class I	Active
Sterile Protective cap for single use	ZRLLCT-1	EUDAMED	Class I	Active
Sterile Protective cap for single use	ZRSPS-10-R	EUDAMED	Class I	Active
Sterile Enteral syringes for single use	58073000050100	EUDAMED	Class I	Active
Sterile Injection kits for single use	MCW253823	EUDAMED	Class IIa	Active
Sterile Syringes For Insulin for single use	JI3000	EUDAMED	Class IIa	Active
Sterile syringes for single use	SR11101232508	EUDAMED	Class IIa	Active
Sterile Syringes For Insulin for single use	JI3100	EUDAMED	Class IIa	Active
Sterile extension sets for single use	ET13002	EUDAMED	Class IIa	Active
Sterile Protective cap for single use	LLC	EUDAMED	Class I	Active
Baby Nasal Irrigator	1400000200	EUDAMED	Class I	Active
Sterile extension sets for single use	ET13003	EUDAMED	Class IIa	Active
Sterile Zero residual small volume syringe without needle for single use	ZSR11202PC	EUDAMED	Class I	Active
Sterile Enteral syringes for single use	58076000060100	EUDAMED	Class I	Active
Terumo	SENG-01L2325R	FDA UDI	Class II	Active
Terumo	SENG-2713R	FDA UDI	Class II	Active
Terumo	SENG-2325R	FDA UDI	Class II	Active
Terumo	SENG-1825R	FDA UDI	Class II	Active
Terumo	SENG-03L2525R	FDA UDI	Class II	Active
Terumo	SENG-2238R	FDA UDI	Class II	Active
Terumo	SENG-01L2525R	FDA UDI	Class II	Active
Terumo	SENG-01L2516R	FDA UDI	Class II	Active
Terumo	SENG-01L2713R	FDA UDI	Class II	Active
Terumo	SENG-2525R	FDA UDI	Class II	Active
Terumo	SENG-2338R	FDA UDI	Class II	Active
Terumo	SENG-1838R	FDA UDI	Class II	Active
Terumo	SENG-03L2516R	FDA UDI	Class II	Active
Terumo	SENG-03L2538R	FDA UDI	Class II	Active
Terumo	SENG - SS-01L	FDA UDI	Class II	Active
Terumo	SENG-2538R	FDA UDI	Class II	Active
Terumo	SENG-2516R	FDA UDI	Class II	Active
Terumo	SENG-3013R	FDA UDI	Class II	Active

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Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

Importers

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Authorities

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