Great news... The first high-flow MDR certificate in China-a new glory than Yang Medical!
Release time:
2023-04-18 14:45
Source:
On April 14, four products independently developed by Hunan Biyang Medical Technology Co., Ltd.Obtain the EU CE MDR certificate issued by TÜV SÜD (TÜV SÜD)It is approved for sale on the EU market. This isThe first domestic high-flow respiratory humidification therapeutic instrumentThe MDR certificate is alsoFirst in Hunan ProvinceNew MDR certificate.
The scope of this certification includes high-flow respiratory humidification therapeutic apparatus and three respiratory diagnosis and treatment consumables, which also indicates that these products of Biyang Medical will take the lead in landing in the European market on behalf of domestic brands, opening the key first step for Biyang Medical products to switch MDR as a whole.
High flow respiratory humidification therapeutic apparatus
Heating Breathing Line
Humidification water box
nasal oxygen tube
CE certification, as the "access certificate" for products to enter the European market, is a mandatory requirement for product access in the EU market. The MDR regulation came into effect on May 26, 2017 and will be enforced on May 26, 2021. It will formally replace the current EU Medical Device Directive (MDD,93/42/EEC) and Active Implantable Medical Device Directive (AIMDD,90/385/EEC). After MDR is enforced, the EU will no longer issue MDD CE certificates for new products, the MDD certificate of old products (legacy devices) will expire on the validity period of the certificate or on May 25, 2024, that is, from May 26, 2024, all products sold to the EU market will be certified according to MDR. After the implementation of the MDR regulation, the EU market access threshold will be comprehensively raised.
Byan Medical will take MDR-CE certification as a new development opportunity to further deepen the global market layout and contribute to the global medical industry.
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