China NMPA legacy archive 鲁械注准20252140056Disposable Sterile Auxiliary Pack
一次性使用无菌辅助包
Shandong Zhushi Pharmaceutical Group Co., Ltd.Class IINMPAApproved January 28, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- ZS-FZB-A综合包、ZS-FZB-I拆线包、ZS-FZB-II口腔护理包、ZS-FZB-III透析护理包、ZS-FZB-IV PICC插管消毒包、ZS-FZB-V会阴护理包、ZS-FZB-VI胃镜检查包、FZB-VII吸痰辅助包、ZS-FZB-VIII急救包。
- Approval department
- Shandong Provincial Drug Administration
山东省药品监督管理局
Registration information
- Registration number
- 鲁械注准20252140056
- Approval date
- January 28, 2025
- Expiry date
- January 27, 2030
Registrant
- Province/Region
- Shandong
- Address
- South of Fanlou Road, Shanxian Development Zone
山东
单县开发区樊楼路南
Production facility
- Production address
- 山东单县经济技术开发区食品药品产业园单德路6号
Intended use
English
本产品主要适用于临床护理、抢救及治疗中的辅助检查使用。
Structure and composition
English
一次性使用无菌辅助包(以下简称辅助包)由以下配件组成： 主要配件：拆线剪、止血带、无菌棉球、医用纱布块、压舌板、灭菌橡胶外科手套、口镜、探针、洞巾、无菌阴道扩张器、消毒刷、鼻胃肠管、口垫、吸痰管、手术刀、带线缝合针、手术刀片。 辅助配件：塑料托盘（大）、塑料托盘（小）、透明塑料托盘（小）、敷料镊、一次性使用手术钳、医用检查手套、PE检查手套、包巾、医用棉签、纱布绷带、吸水纸、治疗巾、无菌敷贴、医用压敏胶带、酒精棉球、碘伏棉球、塑料碗、医用输液贴、医用中单、透气胶带。
Additional information
- Appendix
- 产品技术要求
About this record
This static archive preserves historical registration fields and translations for Disposable Sterile Auxiliary Pack, registration 鲁械注准20252140056. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.