Shandong Zhushi Pharmaceutical Group Co., Ltd
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000024297 FEI 3013496867
- Devices
- 10
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- SUNGO Europe B.V.NL
What Shandong Zhushi Pharmaceutical Group Co., Ltd makes
The company manufactures single-use medical consumables, including disposable nitrile and vinyl examination gloves, surgical gowns, and face masks. It also produces infusion sets with needles, disposable syringes (including insulin and hypodermic types), and liquid dressings. Additional products include infrared thermometers, cooling gel patches, and medical antipyretic gels.
These devices are classified as Class I or Class II under regulatory frameworks and are recorded in the EUDAMED database and the FDA’s 510(k) registry. The company is based in China.
Catalogue
Disposable Nitrile Examination Gloves Ref K203436
Regimes: 510(k) Registry: 510(k)Disposable Surgical Gown Ref K210510
Regimes: 510(k) Registry: 510(k)Disposable infusion set with needle Ref K232475
Regimes: 510(k) Registry: 510(k)Infrared Thermometer Ref K203454
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Disposable Vinyl Examination Gloves Ref K203439
Regimes: 510(k) Registry: 510(k)Disposable Surgical Face Mask Ref 17.5cmx9.5cm
Regimes: CE MDR 510(k) Registry: EUDAMEDCooling Gel Patch Ref 50mmx120mm
Regimes: CE MDR Registry: EUDAMEDLiquid Dressing Ref 30mL
Regimes: CE MDR Registry: EUDAMEDMedical Antipyretic Gel Ref 30g
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000024297
- FDA FEI number
- 3013496867
- EU VAT number
- 9137172275746005XX
- EUDAMED status
- Active
- EUDAMED registered name
- Shandong Zhushi Pharmaceutical Group Co., Ltd
- Registered address
- No 6th, food and drug industry park ,economic and technological development zone,shan county,274300 Heze ,Shandong, PEOPLE'S REPUBLIC OF CHINA, 274300, Heze City, Shandong, China
- [email protected]
- Phone
- +86-530-4265777
- PRRC contact
- Junhui Zhu
Frequently asked questions
How many devices does Shandong Zhushi Pharmaceutical Group Co., Ltd have in the registry?
The registry currently lists 10 devices for Shandong Zhushi Pharmaceutical Group Co., Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shandong Zhushi Pharmaceutical Group Co., Ltd's devices?
Among its 10 most recently registered devices, Shandong Zhushi Pharmaceutical Group Co., Ltd has devices listed in EUDAMED (4 devices) and FDA 510(k) (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Shandong Zhushi Pharmaceutical Group Co., Ltd's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Shandong Zhushi Pharmaceutical Group Co., Ltd's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shandong Zhushi Pharmaceutical Group Co., Ltd in the registry?
The most recently registered devices listed for Shandong Zhushi Pharmaceutical Group Co., Ltd include Disposable Nitrile Examination Gloves, Disposable Surgical Gown, Disposable infusion set with needle and Infrared Thermometer.