Badim
PRODUCT INFORMATION
NAME
BADIM
Packaging
Total 10000 needles per box (large box/10 boxes/1000 needles per box/10 needles per blister)
How to use
Should be performed by a certified professional.
Storage Condition
Store at room temperature. Avoid direct sunlight. Please refer to Instruction for Use for more details.
VENDOR
T.A Bio Tech Co., Ltd.
PRODUCT INTRODUCTION
The history and splendor of Korean medicine for the whole world. DERMAKOR presents disposable sterile needles for acupuncture therapy. Sterile disposable medical device.
The Unique Qualities of Badim
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Materials
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Improved sharpening process and high quality components
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Production system
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Innovative and hygienic automatic assembly system
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Safe method of sterilization and sanitization
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System for the implementation of barcodes and PDAs
Packing: Total 10000 needles per box (large box/10 boxes/1000 needles per box/10 needles per blister)
BADIM Acupuncture Needles
Hand Acupuncture Needle (Blister Package)
General Needle (Plastick Package)
Hand Acupuncture Needle
(Blister Package)
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General Needle
(Plastick Package)
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T/L |
15мм |
25мм |
30мм |
40мм |
50мм |
60мм |
|---|---|---|---|---|---|---|
|
0,20 |
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0,25 |
|
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0,30 |
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|
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|||
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0,35 |
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The Unique Qualities of BADIM
ONLY BADIM'S FEATURES
production system Innovative automatic assembly system Hygienic automatic packing system
Safe sterilization method Sterilization and sanitization System for the realization of bar codes and PDAs
The only Badim’s manufacturing tech & automatic system
Innovative automatic assemble system
BADIM’s automatic assemble system automatically assembles primary operated handle and body to maximize product s safety and guarantee convenient during the treatment.
Hygienic automatic packaging system
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The only Badim’s features & materials
Certificates
PATENTS
CERTIFICATES
GMP (Goad Manufacturing Practice)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
FDA (Food and Drug Adm inistration)
The Food and Drug Administration (FDA or US FDA) is a federal agency of the United States Department of Hearth and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods &feed and veterinary products.
CE Marking : 0068 (Community European Marking)
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, rhe EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States.
ISO 13485 (International Organization for Standardization)
IS 013485 Medical devices is Quality management systems. Requirements for regulatory euf poses is an International Organization for Standardization (ISO) standard published for the first time in 1996 it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents sucn as EN 46001 and EN 46002 (both 1997), the previously published ISO 13485, and ISO 13488.
