Zhonghong Pulin Medical Products Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000001108
- Devices
- 66
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
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.
Catalogue
Search and filter all 66 devicesShowing 1-50 of 66
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
- [email protected]
- PRRC contact
- Cuiru Pang
FDA establishments
- Zhonghong Pulin Medical Products Co., Ltd. Tangshan Hebei · CN FEI 3010201834
Frequently asked questions
How many devices does Zhonghong Pulin Medical Products Co.,Ltd. have in the registry?
The registry currently lists 66 devices for Zhonghong Pulin Medical Products Co.,Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zhonghong Pulin Medical Products Co.,Ltd.'s devices?
Among its 50 most recently registered devices, Zhonghong Pulin Medical Products Co.,Ltd. has devices listed in EUDAMED (49 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Zhonghong Pulin Medical Products Co.,Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Zhonghong Pulin Medical Products Co.,Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Zhonghong Pulin Medical Products Co.,Ltd. in the registry?
The most recently registered devices listed for Zhonghong Pulin Medical Products Co.,Ltd. include Disposable examination and protective nitrile gloves KORAKO MEDICAL, Nitrile exam glove, Blue, powder free, 3.5g, Nitrile blue gloves, Powder free S and Nitrile exam glove, Blue, powder free, 5g.
Which FDA establishments are linked to Zhonghong Pulin Medical Products Co.,Ltd.?
1 FDA establishment is linked to Zhonghong Pulin Medical Products Co.,Ltd. in the registry; they are listed on the company page.