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Zhonghong Pulin Medical Products Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED FDA SRN CN-MF-000001108

Devices
66
Registrations
EUDAMEDFDA
FDA recalls
0

What Zhonghong Pulin Medical Products Co., Ltd. makes

The company manufactures single-use nitrile gloves designed for diagnostic and medical procedures, including powder-free variants in sizes ranging from extra-small to extra-large. These gloves are intended for clinical examinations, laboratory work, and other medical applications requiring barrier protection against pathogens and chemicals. The product line includes blue-colored nitrile gloves, which are commonly used in healthcare settings for visibility and comfort.

The portfolio consists of Class I medical devices, which are generally considered low-risk and subject to minimal regulatory oversight. These gloves are listed in the EU’s EUDAMED database and have been submitted for 510(k) clearance via the FDA’s premarket notification process. The manufacturer is based in China and adheres to relevant regulatory requirements for these device categories.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

EUDAMED SRN
CN-MF-000001108
EU VAT number
911302005661986189
EUDAMED status
Active
EUDAMED registered name
Zhonghong Pulin Medical Products Co.,Ltd.
Registered address
West Industrial Park, Luannan County,, 063500, Tangshan, China
PRRC contact
Cuiru Pang(public in EUDAMED)

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Zhonghong Pulin Medical Products Co., Ltd. Tangshan Hebei · CN FEI 3010201834