APPROVALS & CERTIFICATIONS
ASK4MASK®masks are manufactured in Romania in a controlled and hygienic environment. They are tested and certified in accordance with European safety and quality standards.
THE IMPORTANCE OF MEDICAL MASK CERTIFICATION ASK4MASK®
We chose local production because we wanted complete control over the quality, safety, and standards of the final product.
ASK4MASK® stands for responsibility, rigorous testing, and confidence in a product manufactured in Romania according to European standards.
CERTIFICATIONS
ISO 9001:2015
Certified quality management system for the design, production, and marketing of disposable medical masks.
ISO 13485:2016
Certified medical device quality management system for the design, manufacture, and distribution of disposable medical masks.
EN 14683:2019 Tip IIR
Tested in accordance with the European standard for medical masks.
Provides bacterial filtration efficiency and protection against fluid splashes.
ISO 22609:2004 (Splash Resistant)
Resistance to synthetic fluid penetration (Splash Resistance), tested to ensure protection against splashes and liquid particles.
APPROVALS & REGISTRATIONS
Medical Device Registration ANMDMR
Registered as a medical device Class I in accordance with Regulation (EU) 2017/745.
GS1 Romania License
GS1 certified for the identification and traceability of ASK4MASK® products through barcodes and international UDI standards.
OSIM Registered Trademark
Official trademark registration certificate for ASK4MASK® at OSIM (State Office for Inventions and Trademarks).
TEST REPORTS
Bacterial Filtration Efficiency (BFE)
Tested in accordance with EN 14683:2019.
Bacterial filtration efficiency ≥ 99%.
Breathability
Tested in accordance with
EN 14683:2019
Type IIR PASS – easy
to breathe
during extended use.
Cytotoxicity Test
Tested in accordance with
ISO 10993-5 și ISO 10993-12
Non-cytotoxic materials,
safe for skin contact
Splash Resistance
Tested in accordance with
ISO 22609:2004
Protection agains
fluid penetrationand
synthetic splashe
Microbiological Cleanliness
(Microbial Cleanliness)
Tested in accordance with EN 14683:2019
Microbiological control verified to ensure high hygiene standards
DOCUMENTS
ASK4MASK® Technical Specifications (RO)
Complete technical specifications for the ASK4MASK® Type IIR medical mask, in accordance with applicable European standards.
EU Declaration of Conformity
Certificate of conformity for the ASK4MASK® Type IIR medical mask with the requirements of Regulation (EU) 2017/745 (MDR).
Instructions for Use ASK4MASK®
Instructions for use, storage, and disposal of the ASK4MASK® Type IIR medical mask, as well as user safety warnings.
Shelf Life Declaration for Masks
Manufacturer’s declaration issued in accordance with the technical documentation of the ASK4MASK® product.
SIMPLIFYING THE ORDER PROCESS
After reviewing the request, the ASK4MASK® team will send a personalized commercial offer, together with estimated production and delivery times.
Upon confirmation of the received offer, orders are finalized by completing the firm order form available below, followed by official confirmation of order processing from our team.
Firm purchase order B2B
Document intended for submitting firm orders for ASK4MASK® medical products and B2B commercial collaborations.
WE OFFER COMPATIBILITY FOR RETAIL AND DISTRIBUTION
ASK4MASK® products are prepared for integration into retail networks and modern distribution systems.
✔ GTIN codes for standardized identification
✔ Efficient product traceability
✔ Compatibility with commercial and logistics systems
✔ Retail-ready packaging
✔ Optional palletization available at an additional cost
WE MANUFACTURE TO EUROPEAN QUALITY STANDARDS
ASK4MASK® Type IIR medical masks are made from high-quality materials and provide effective protection through a 3-layer structure.
The products are evaluated in accordance with European standards and manufactured under a certified quality management system.
WE MEET THE REQUIREMENTS OF THE MEDICAL AND COMMERCIAL SECTORS
The ASK4MASK® production facility has a minimum production capacity of 500,000 masks per month, ensuring consistent supply and large-volume deliveries.
Our products are intended for cooperation with hospitals, clinics, institutions, pharmacies, distributors, and retail partners.