Vaginal Speculum (lmiddle screw type )(CE0197,ISO13485:2003,ISO9001:2000)

Our factory's vaginal speculum with CE marks are used very widely in gynecology field in many hostpitals and clinics.

Features:

1.Item Name : vaginal speculum, vaginal specula,vaginal dilator.

2.Types: middle screw type.

3.Sizes: Large,Medium,Small.( In compliance with international standrad )

4.Material: polystyrene ( short for :PS )

5.Packing : 1 pcs/bag,100 bags/carton.We have three types of bag for our customers choice.They are polyethylene bag (PE bag),polypropylene bag (PP bag),and paper-plastic bag. The carton size is :52*39*32 cm

6.Function:They are widely used for vaginal examination and treatment.

7.Instruction of use: Before use, the users must read the usage manual, and then take the speculum, push the duckbill of speculum   which is closed into the vagina slowly. Open the  duckbill of speculum according to the demand, fix the nut of the speculum, then it can be used in checking and treatment gynecology disease. After all, loose the nut of the speculum, take the duckbill of speculum out of the vagina slowly.

Caution:

·The speculum is for single use only and must be destroyed after use .Reuse is prohibited.

·Sterilization guaranteed if package unopened. Use the speculum immediately after opened. 

·Stored in a cool and dry place.

8.Sterilization: Our factory has sterilization chamber . By EO gas. nontoxic

9.Service : OEM service is available.

10.usage custom:

(1).lateral screw type:often used in Europe,Southeast Asia and some Africa countries and so on.

(2).push type :often used in Usa,Canada and Latin America and so on.

(3). middle screw type :often used in middle-east,UK ,Italy and so on.

(4).fastener type :often used in France ,Poland and so on.

 

 

Vaginal Speculum (lmiddle screw type )(CE0197,ISO13485:2003,ISO9001:2000)

Verified Information This information is Verified by Bureau Veritas and validity period is 2012/08/10 --- 2013/08/10 All the information below may covers both Gold Supplier and its related companies , Their Relationship will be affirmed according to china laws and regulations , also it will be clearly display in the full report >> Production Capacity: Product line name Production Line Capacity Actual Units Produced(Previous Year)

Vaginal Speculum, Vaginal Irrigator, PE Gloves, Medical Cotton Stick	32,280,000 sets per year	confidential

Export Market Distribution: Market Revenue(Previous Year) Total Revenue (%)

Eastern Europe	confidential	15.0
Mid East	confidential	15.0
Western Europe	confidential	23.0
South Asia	confidential	17.0
Domestic Market	confidential	30.0

Production Machinery: Machine Name Brand & Model No. Quantity Number of Year(s) Used Condition

Injection machine	HAITIAN	10	6.0	Acceptable
Auto sealing machine	HM500DE	6	1.0	Acceptable
Film blowing machine	SL-55-FM1000	3	1.0	Acceptable
Film gloves molding machine	No information	4	1.0	Acceptable
Packing machine	KANGHUA	4	3.0	Acceptable
Sterilizing machine	HDX-20	2	1.0	Acceptable

Testing Machinery: Machine Name Brand & Model No. Quantity Number of Year(s) Used Condition

GC analyzer	GC-2014C	1	2.0	Acceptable
Constant temperature cultivating box	HH-B11-600.S	2	6.0	Acceptable
Mildew bacterium cultivating box	MJ-160	1	8.0	Acceptable
Peeling tester	BLD-200N	1	1.0	Acceptable
Flexivity and strength tester	KRQ0336-B	1	1.0	Acceptable
Spectrophotometer	722S	1	10.0	Acceptable
Laser dust counting machine	Y09-301	1	3.0	Acceptable
Wind velocity tester	QDF3	1	8.0	Acceptable
Electronic balance	AL204/210g	1	2.0	Acceptable

Production Flow: 1.Injection 2.Assembling 3.Packing 1 4.Sealing 5.Packing 2 6.Sterilization Certification: Certified Picture Certification Name Certified By Certificate No. Product Name & Model No. Available Date-Expired Date

	CE	TUV	DD600416840001	Manufacture of Medical Devices (Aspects of Manufacture Concerned with Securing and Maintaining Sterile Conditions: Sterile Vaginal Speculum for Single Use, Disposable Cervical Brushes, Disposable Cervical Spatulas, Disposable Cervical Cell Sampling Spoons)	2011/11/21 --- 2015/09/19

Testing Report: Report Picture Report Name Report By Product Name & Model No. Report Date

	Test Report	Zhejiang Institute for the Control Medical Device	Disposable Vaginal Speculum & Medium-sized	2009/07/31
	Test Report	Zhejiang Institute for the Control Medical Device	Disposable Vaginal Speculum & Medium-sized Kelin type	2008/11/19