Dear our valued customers,
After years of preparation for MDR certification, GaleMed is absolutely thrilled to share with you that GaleMed I-Lan plant has obtained a MDR certificate (Certificate No. HZ2100418-1) for all our Class I, Im and II products. We are proud to be one of the pioneers in this regard. For more detailed information please lick here: Link。
Our MDR certification includes 19 EMDN codes and GaleMed portfolio’s 1069 SKUs. In addition, it covers all ranges of disposable peripherals and some reusable peripherals for respiratory cares.
Please see below a list of the scope of the specific products covered by our MDR certificate for your reference:
- R020101 - STANDARD BREATHING CIRCUITS
- R020102 - COAXIAL BREATHING CIRCUITS
- R020104 - CPAP AND NIV BREATHING CIRCUITS
- R020106 - IPPB CIRCUITS
- R028001 - RESPIRATORY CIRCUITS VALVES
- R028099 - RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
- R030101 - VENTILATION MASKS
- R030102 - AIR/OXYGEN MASKS AND NASAL CANNULAS
- R030103 - AEROSOL THERAPY MASKS AND SYSTEMS
- R030180 – RESPIRATORY MASKS – ACCESSORIES NOT INCLUDED IN OTHER CLASSES
- R030202 – MANUALLY OPERATED VENTILATION BALLOONS
- R030280 - RESPIRATORY BALLONS - ACCESSORIES
- R040102 - ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
- R9001 - RESPIRATORY MOUTHPIECES
- R900902 – INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS
- R9080 – RESPIRATORY AND ANESTHESIA DEVICES – ACCESSORIES NOT INCLUDED IN OTHER CLASSES
- V0380 – DEVICES WITH MEASURING FUNCTIONS – ACCESSORIES
- Z121501 – SPIROMETRY INSTRUMENTS
- Z12150199 – SPIROMETRY INSTRUMENTS - OTHER
We want to sincerely thank YOU for your committed support, which enabled us to continuously achieve outstanding developments.
GaleMed will continue to strive to become a leading global company in the respiratory care space by providing the best clinical solutions to meet the customer’s needs.
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