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
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
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
6, Withdraw the plunger to draw back the needle into the barrel
7, Break off the plunger
8, The syringe has been totally disabledABOUT US:
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
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
In Classic Medical, we believe exceptional service and product
quality can make theirbest value when combining with social
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
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 regulatorypurposes》 and 《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,
Postal code：200335 Tel：86-21-33608531 Fax：86-21-33608581
Name of EC-representative：Eastland Medical System PLC
Address of EC-representative：Suite 9, The Royal 25 Bank Plain， Norwich，Norfolk， NR24SF，United 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）
1—zero scale line；2—sub-scale volume line；3—nominal volume scale line；4—general volume scale line；5—base line；6—coat roll edge; 7—needle tube；8—coat neck；
9—needle stand；10—coat；11—stick head；12—metallic hook；13—piston；14—stick；15—handle；16—coat；17—protective piece
Note：This sketch map is only for illustrating structure of syringe，not 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
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
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
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
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
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
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.