Surgical Face Mask CE Marking and EU Registration is mandatory for marketing the medical device in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices.
Face masks become a symbol in each pandemic period. It is very important to wear a mask for a viral enemy that is unclear where it will come from and is not visible even if it is not hidden. Although people sometimes use a scarf wrapped around their face or colorful homemade textiles that cover the mouth and nose, it is best to use masks or, more rarely, N95 masks for effective and healthy protection.
- As CE mark consultants for medical devices we’ll help you for the process of making a defined technical file with all the product details.
- We will help you in meeting European submission standards that state the product offered is in compliance with the exact requirements of European safety.
The classification of masks is mainly based on the results of the following tests:
- Bacterial filtration efficiency test
- Breathability (delta P) test
- Splash resistance (synthetic blood) test
- Microbial cleaning test
- Biocompatibility test
The basic standard that must be complied with in order to put Surgical Face Mask CE Marking is the TS EN 149 standard (Respiratory protective devices – Half masks with filters for protection against particles – Properties, experiments and marking standard). This standard describes the minimum conditions for half masks with filters, respiratory equipment used for protection against particles that cannot be removed from the environment.
Surgical Face Mask CE Marking
Surgical Face Mask CE Marking as a medical device is theoretically possible but there is no standard for this and in the absence of a widely agreed performance benchmark the rules for CE marking medical devices, which require the manufacturer to have clear evidence that the device provides a medical benefit in response to one or more specific illness or disability, actually make it likely that it will cost more and take longer than the Notified Body procedure for PPE.
CE marking can now be placed on surgical masks that pass these tests under the responsibility of the manufacturer. Surgical Face Mask CE Marking services are also provided to our businesses within the scope of certification services.
Surgical Face Mask CE Marking is approved for safety, health and environmental protection standards. After tests performed in advanced laboratories, masks are classified as N95, N99 and N100 according to their level of efficiency, and CE marking is put on it by rating it as FFP1, FFP2 or FFP3.
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Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
If You Want Medical Devices Services Consultation For Following.- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
