Home > Products > Physically Therapeutic Apparatus > Sterile Disposable Plastic Screw Locked Medium CE Marked Latex Free Plastic Defferent Sizes Vaginal Speculum for Single Use
Sterile Disposable Plastic Screw Locked Medium CE Marked Latex Free Plastic Defferent Sizes Vaginal Speculum for Single Use
- 500000 Piece / Pieces per Month
- Shanghai China
- T/T D/P D/A Credit Card PayPal
Product Details
Type: | Other, Vaginal Speculum | Brand Name: | Huankang |
Model Number: | HK-A06 | Place of Origin: | Jiangsu, China |
Product Description
Specifications
Vaginal Speculum1.Cusco design
2.Clear transparent plastic for good visibility
Sterile Disposable Plastic Screw Locked Medium CE Marked Latex Free Plastic Defferent Sizes Vaginal Speculum for Single Use
Specification Requirements:
1. Cusco design
2. Clear transparent plastic for good visibility
3. Shape of viewing access for optimum viewing, optimum38 degree opening angle
4. Shape of specula - smooth contours on beak to stop skin trapping, handle to provide appropriate grip and control
5. Fail safe mechanism must be built in to the specula design - Patient fail safe feature must be outside of patient
6.Simple locking mechanism for fast, secure locking-thread and nut
7.Strength - product strength/wall thickness adequate for intended use
8.Material of construction should be compatible with most common lubricants used when taking cervical smears in Primary Care settings.
Compliance Requirements:
1.The Products proposed must be sterile and comply with the appropriate national standards incorporating EC Standards including Medical Devices Directive 2007/47/EC and Manufacturing Facility ISO 13485:2003. 2. In the absence of EC standards evidence of compliance to internationally recognised standards for sterilisation/ISO 9001:2000 is desirable
3.All materials used in the construction of the speculum must conform to ASTM, FDA or other relevant or appropriate international standards.
4. Quality Management system standards ISO 13485:2003
Materials:
1.All materials must be non toxic and of known strength. Note that there must be no latex present.
2.All materials used in the construction of the speculum must conform to ASTM, FDA or other relevant or appropriate international standards.
3.Evidence of compliance to internationally recognised standards for sterilisation is required
All individual packaging should be clearly labelled with the following information:
1.Manufacturer’s name, address and contact details.
2. Size of the speculum (unique code number if applicable).
3. Latex free.
4.Sterile X, Where X represents the method of sterilisation.
5. Sterile Class 1 devices will be labelled with the CE mark which will have an accompanying four digit number. This number is unique to the Notified Body who has assessed the capability of the manufacturer to manufacture sterile devices. 6.Where appropriate, the batch code, preceded by the word ‘lot’ or serial number.
7.Indication that the device is for single use.
8.Any special storage or handling conditions.
9.Date of manufacture/sterilization (expressed as the year and month).
10. Indication of the latest date by which the device should be used (expressed as the year and month). 11. Strong packaging - specula does not pierce the packaging and no history of this occurring 12.Quality of plastic used for the specula - must be professional grade medical plastic 13.Product markings - each specula must be CE marked and marked for single use.
All manufacturers box packaging should be clearly labelled with the following information
1 Manufacturer’s name, address and contact details.
2.Size of the speculum (unique code number if applicable).
3.Latex free.
4.Sterile X, where X represents the method of sterilisation
5. CE mark and Notified Body number.
6.Where appropriate, the batch code, preceded by the word ‘lot’ or serial number.
7.Indication that the device is for single use.
8. Any special storage or handling conditions.
9. Date of manufacture/sterilization (expressed as the year and month).
10.Indication of the latest date by which the device should be used (expressed as the year and month).
11.The shipping unit quantity must be specified for each size.
Company profile:
Chongqing Joywell Trade Co.,Ltd. was founded Chongqing China in 1999, It has a professional team to engage at international business and a long-term cooperated factories as powerful backing.
Qulity spirit, wonderful service and team work are always the first. Through develop more than 10 years, we have lifted up a new stage and established a wide customer group which from United States, United Kingdom, Cannada, Germany, Japan, South Korea, Iran, New Zealand, Qatar, Irealand, Spain, Netherland, Chile, etc.
The team cooperation open up and share innovation.
AIM: Employee's success is the success of the company.
VALUE: Intergrity first, customer first, cooperation sharing, happy passion, refince on active, thanksgiving growth.
MISSION: Let customer satisfaction, let the Joywell products are well-known in the world.
VISION: To meet the challenge, success!
We would like cooperate with clients from all over the world.
Contact Us
- Chongqing Joywell Trade Co., Ltd.
- Contact nameFelix Chen
- Phone86-23-67726679,67742083
- AddressRoom 6, 17/F, Unit 6, Mantanghong House, No. 3, Yanghe Second Village
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