Shandong Aosaite Medical Devices Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000010956
- Devices
- 131
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
Catalogue
Search and filter all 131 devicesShowing 1-50 of 131
Company details
- EUDAMED SRN
- CN-MF-000010956
- EUDAMED status
- Active
- EUDAMED registered name
- Shandong Aosaite Medical Devices Co.,Ltd.
- Registered address
- No.3 North Ring Road, Chengwu County, Heze, 274200 Shandong, P.R. China, 274200, Heze, Shandong, China
- [email protected]
- PRRC contact
- Jie Zhang
EUDAMED certificates
2 certificates2 valid, 0 expiredIVDR 1, MDR 1next expiry 11 Mar 2029
BSI Group The Netherlands B.V. 2797 1 certificate
- IVDR 791597 Active
Quality management system EU IVDR
- Issued
- 12 Mar 2024
- Expires
- 11 Mar 2029
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2365105-1 Active
Quality management system EU MDR
- Issued
- 26 Aug 2024
- Expires
- 25 Aug 2029
Frequently asked questions
How many devices does Shandong Aosaite Medical Devices Co.,Ltd. have in the registry?
The registry currently lists 131 devices for Shandong Aosaite Medical Devices Co.,Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shandong Aosaite Medical Devices Co.,Ltd.'s devices?
Among its 50 most recently registered devices, Shandong Aosaite Medical Devices Co.,Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do Shandong Aosaite Medical Devices Co.,Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Shandong Aosaite Medical Devices Co.,Ltd.'s devices are Class IIa and IVDR Class A. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Shandong Aosaite Medical Devices Co.,Ltd.?
EUDAMED lists 2 certificates for Shandong Aosaite Medical Devices Co.,Ltd. (quality management system) under MDR and IVDR. 2 are recorded with the status issued. The most recent was issued on 26 Aug 2024.
What are the newest devices from Shandong Aosaite Medical Devices Co.,Ltd. in the registry?
The most recently registered devices listed for Shandong Aosaite Medical Devices Co.,Ltd. include Disposable Blood Collection Needles and Vacuum Blood Collection Tubes.