Heyer Care Co.，Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000029617
- Devices
- 59
- Registrations
- EUDAMED
Catalogue
LuvOn N2 Nasal Mask Ref 111500181
LuvRes F1NV Non-Vented Mask Ref 111500248
LuvOn N3 Nasal Mask Ref 111500209
LuvOn N1 Nasal Mask Ref 111500178
LuvOn N3 Nasal Mask Ref 111500211
LuvOn F3 Full Face Mask Ref 111500171
LuvOn F1 Full Face Mask Ref 111500241
LuvOn F3 Full Face Mask Ref 111500246
LuvOn F2 Full Face Mask Ref 111500243
Showing 51-59 of 59
Company details
- EUDAMED SRN
- CN-MF-000029617
- EUDAMED status
- Active
- EUDAMED registered name
- Heyer Care Co.，Ltd.
- Registered address
- Room 301, Building 1, No.8 Baicao road, Daxing District, Beijing, China, 102609, Beijing, China
- [email protected]
- PRRC contact
- Dongxu Wang
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 21 Jan 2029
TÜV SÜD Product Service GmbH 0123 1 certificate
- G15 117055 0006 Amended
Quality management system EU MDR
- Issued
- 2 Sep 2026
- Expires
- 21 Jan 2029
- Reason
- Mnf data change
What Heyer Care Co.，Ltd. makes
Heyer Care Co., Ltd. manufactures non-vented and nasal pillows masks for respiratory therapy, including the LuvRes F2NV and F1NV series, as well as the LuvOn P1 nasal pillows mask. These devices are designed for continuous positive airway pressure (CPAP) and related respiratory support applications.
The company’s products are classified as Class IIa medical devices and are registered in the EU’s eudamed database. The portfolio is regulated under EU Medical Device Regulations (MDR) and aligns with applicable conformity assessment procedures for this class.