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0.3ml Retractable Safety Syringe Auto-disable Syringe Ad Syringe Safe

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Classic Medical Tech (SHA) Co., Ltd

0.3ml Retractable Safety Syringe Auto-disable Syringe Ad Syringe Safe

Packaging Details : PE
Payment Terms : T/T, L/C
MOQ : 200000 Piece
Brand Name : ts-a
Properties : Injection & Puncture Instrument
Place of Origin : CHINA
Category : Syringe
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High transparent pp provides clear graduation visibility.
Full automation assemble line makes mass production easily.
The patented safety mechanism is an integrated part of the syringe without add-on pieces.
Tab at the end prevents pre-activation during transportation or before injection.
Clinicians’ hands and fingers remain behind the sharp at all times
Minimal dead space, Minimize waste in medication
The needle is securely protected inside the barrel and remains protective during disposal.
No Recapping required.
Largely save on disposal cost
Usage instruction:
1, Remove the needle cover
2, Draw up medication as per protocol
3, Remove the confining piece
4, Remove air bubbles
5, Push the plunger to inject and lock the needle when medication finished
6, Withdraw the plunger to draw back the needle into the barrel
7, Break off the plunger
8, The syringe has been totally disabled
Classic Medical is the pioneer safety injection products and service provider company in the world with efforts continuously being put on the developing and researching of safety injection solutions.
Since the establishment of year 2002, we have been promoting safety injection globally with the commitment of making safety injection within reach for all.
With this commitment in mind we have during these years providing safety syringes to both domestic governments and overseas at economic price and superior quality, help billions get safety injection by providing unmatched value products and outstanding service.
In Classic Medical, we believe exceptional service and product quality can make theirbest value when combining with social responsibility.
We will consistently do what have been doing and go beyond
1 Introduction of the company
1.1 Overview of the company
The reformation of international and domestic medical device for single use market is coming. The R&D team established the “single Use Medical Device Improvement Institute” in Shanghai in 2000, which mainly focus on R&D and improvement of single use medical devices. In 2003, the first product “TS-ARetractable Safety Syringe Single Use Only” with patent was completed, and the patent application was submitted to National Intellectual Asset Bureau.
    To hold the coming of domestic and international market opportunity, Classic Medical Tech (SHA) Co., Ltd. was established in Dec. of 2003. The personnel include personnel of original R&D personnel of Jinyue Institute, specialists from various scope, including overseas personnel back to China, nurses, R&D management personnel more than 10 persons. Other than strong R&D force, the company has the stage planning for new product marketing, the objective is holding a certain market share in 2 years.
The products in marketing of our company will all have independent intellectual asset. This plentiful immateriality asset will be the first backbone of our company to enter the capital market in the future.
The quality policy of our company is:
“Accurate and fine, scientific and creative”
The quality objective of our company is:
① Establish a perfect quality management system,effectively implement and continually improve,ensure the certification of ISO 13485:2003《Medical devices — Quality managementsystems — Requirements for regulatorypurposesand 《Medical Device Directive of EC》( 93/42/EEC:1993).
② Take the 6σ as quality management measure, pursue the best level of international;quality level achieves 3σ in 1 year.
③ The product quality conforming to national requirement, and the conformity rate in inspection for delivery achieve 100%.
1.2 The company
Address:Room 16-D, No.2, Lane 600, TianShan Road, ChangNing District, ShangHai, Chin
Postal code:200335   Tel:86-21-33608531    Fax:86-21-33608581
1.3 EC-representative
Name of EC-representative:Eastland Medical System PLC
Address of EC-representative:Suite 9, The Royal 25 Bank Plain NorwichNorfolk NR24SFUnited Kingdom
Tel: 44 (1603) 283 489
Fax: +44 (1603) 766 359
2 Description of the product
2.1 Description of the product
The syringe for single use is a common product widely used in domestic and international medical units. The Retractable Safety Syringe Single Use Only manufactured by our company use same raw materials with common syringe for single use, it is not a completely new product, it just improves the exist product and adds the safety and self-destroy function after injection.
2.2 Components of the product
The components of product include coat, needle tube, needle stand, protective coat and piston.
2.3 Intended use of the product
The Retractable Safety Syringe Single Use Only is used for clinical injection for sufferer. The injection process is very same as traditional syringe, the difference is after injection, the needle tube is retractable to ensure single use and prevent cross infection in injection.
3 Pattern of the product (see Fig. 1)
1zero scale line2sub-scale volume line3nominal volume scale line4general volume scale line5base line6coat roll edge; 7needle tube8coat neck
9needle stand10coat11stick head12metallic hook13piston14stick15handle16coat17protective piece
NoteThis sketch map is only for illustrating structure of syringenot indicate the only pattern specified by standard.
Fig. 1 Retractable Safety Syringe Single Use Only
4 Performance of the product
4.1 The Retractable Safety Syringe Single Use Only is improved based on traditional syringe for single use.
4.1.1 There added a stick head on stick part, and assembly a metallic hook.
4.1.2 The match of needle stand and coat was changed from assembly inside to assembly outside.
4.1.3 There is break fracture and protective piece.
4.2 The raw materials and production technique is basically same as traditional syringe for single use.
4.3 Performance other than safety and self-destroy please refer to ISO 7886-1:1993/ GB 15810—2001《Sterile Syringe for Single Use》和ISO 7864:1993/ GB 15811—2001《Sterile Syringe Needle for Single Use》.
4.4 The structure and safety and self-destroy function of Retractable Safety Syringe Single Use Only refers the needle stand assembled in inside of coat neck. After injection, the metallic hook on head of stick inserts the needle stand, the stick will lock with needle stand which causes destroy, pull back the stick at that time, the needle tube will retract to coat completely, which achieves safety function.
5Precautions in use of the product
5.1 Use before expiry date. Use after expiry date is forbidden;
5.2 Check if there is foreign substrates in unit package before use. Do not use if there is foreign substrate;
5.3 For single use only. Use immediately after unit package opened;
5.4 Do not use if package is broken.
5.4 Do not use if there is other abnormal issues.
5.5  Store the product with conditions of humidity not more than 80%,temperature not higher than 40℃,no erosive gas and with good aeration. The humidity-proofing and disinfection-proofing shall be considered.
6 Specifications of the product
There are 8 specifications of Retractable Safety Syringe Single Use Only: 0.1ml, 0.3ml, 0.5ml, 1ml, 2ml, 3ml, 5ml, 10ml.
7 Accessories and package of the product
Each Retractable Safety Syringe Single Use Only is packaged in a unit package. Each 120~300 unit packages are put in middle package, and each 6~8 middle packages are put in outer package because of the limitation of size.
8 Classification of the product
According to classification rule of 《Medical Device Directives》(93/42/EEC:1993), the Retractable Safety Syringe Single Use Only manufactured by our company is classified as Class Ⅱa product.
9 Conformity routine of the product
Select the certification routine according to 《Medical Device Directives》(93/42/EEC:1993)Annex II.

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