Shenzhen Hainwise Medical Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000037066
- Devices
- 97
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- Authorised rep.
- Kingsmead Service B.V.NL
What Shenzhen Hainwise Medical Technology Co., Ltd. makes
Shenzhen Hainwise Medical Technology produces guidewires for vascular and urinary tract procedures, including angiographic guidewires and hydrophilic guidewires designed for urinary tract applications.
The company’s devices are classified as Class IIa under EU regulations and are listed in the EUDAMED registry. The manufacturer is based in China.
Catalogue
Search and filter all 97 devicesShowing 1-50 of 97
Company details
- EUDAMED SRN
- CN-MF-000037066
- DUNS number
- 618556012
- EUDAMED status
- Active
- EUDAMED registered name
- SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
- EUDAMED abbreviated name
- HAINWISE
- Registered address
- No. 22, Longwo 4th Road, Longtian Street, 518122, Shenzhen, Guangdong, China
- [email protected]
- Phone
- 15875314723
- PRRC contact
- Yulan Mao
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 20 Apr 2030
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2514782-1 Active
Quality management system EU MDR
- Issued
- 21 Apr 2025
- Expires
- 20 Apr 2030
Frequently asked questions
How many devices does SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD. have in the registry?
The registry currently lists 97 devices for SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.. Devices recorded under merged duplicate company entries are counted once.
Which registries list SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.'s devices?
Among its 50 most recently registered devices, SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD. has devices listed in EUDAMED (50 devices) and FDA GUDID (23 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.?
EUDAMED lists 1 certificate for SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 21 Apr 2025.
What are the newest devices from SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD. in the registry?
The most recently registered devices listed for SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD. include Angiographic Guidewire, Zebra Guidewire for Urinary Tract and Hydrophilic Guidewire for Urinary Tract.