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Manufacturer Name (on which the certification need to be done)
Manufacturer Address with legal entity (on which the certification need to be done)
Contact Person (S)
Contact Number (S)
Email Address (S)
Product Generic Name
Brand Name for product
Product Category
Are we applying CE Certification for the 1st time
Yes
No
When the product was 1st placed in the market
Intended use of device
Purpose to use the device (Mechanism of Action)
GMDN Code
Diseases & Condition where the product can be used
On which patient population Product should be used for eg. paediatric
Intended User
At which part of body the product can be used
How long product can be in contact with body
Less than 60 mins
Between 60 mins to 30 days
More than 30 days
Product reusable or Single use
Reusable
Single use
Countries where product are placed
Condition where the product should not be used or extra care should be taken (Precaution)
Warnings while using the Product
Material used for device (Material of Construction) Kindly provide their MSDS, COA, testing reports
Does product emit radiation? If yes, what kind?
Yes
No
Manufacturing Flow chart of product
Upload your file...
Principal of Operation of product (Surgical Techniques)
Do product is sterile? If yes kindly provide the sterilization method.
Yes
No
Does product incorporates a medicinal substance /animal tissues, or blood components
Yes
No
Whether the device is intended to cover medical needs that are otherwise unmet
Is there medical alternatives to the device
Competitor companies having CE mark
Is product based on predecessor devices
pro
Yes
No
State of Art (related to product)
Common word used for the product.
Specific product literature available from manufacturer
Yes
No
Design dossier for product with actual image of product
Available
Not Available
Product contain software? if yes, kindly provide version of software, model name, off the self legacy?
Yes
No
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