Baoding Te'Anzhou Electronic Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000048827
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
What Baoding Te'Anzhou Electronic Technology Co., Ltd. makes
Baoding Te'Anzhou Electronic Technology Co., Ltd. manufactures medical diode laser systems, including the TR-B series and the VeinCure model, designed for therapeutic applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Laser Surgery Instruments Ref TR-B
CE MDR EUDAMEDGUDIDLaser Surgery Instruments Ref VeinCure
CE MDR EUDAMEDGUDIDMedical Diode Laser Systems (TR-B) Ref K252658
510(k) 510(k)Medical Diode Laser Systems (VeinCure) Ref K252564
510(k) 510(k)
Company details
- EUDAMED SRN
- CN-MF-000048827
- EUDAMED status
- Active
- EUDAMED registered name
- Baoding Te’anzhou Electronic Technology Co.,Ltd.
- Registered address
- Room 1702, 17th Floor, Zhibo Technology Comprehensive Research And Development Building, 89 Hengbin Road, 071000, Baoding, Hebei, China
- [email protected]
- PRRC contact
- Wenjia Shang
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 19 Aug 2031
Notified body 2797 1 certificate
- MDR 830907 Issued
Quality management system EU MDR
- Issued
- 20 Aug 2026
- Expires
- 19 Aug 2031
FDA establishments
- Baoding Te'anzhou Electronic Technology Co., Ltd. Baoding Hebei · CN FEI 3031582430
Frequently asked questions
How many devices does Baoding Te'Anzhou Electronic Technology Co., Ltd. have in the registry?
The registry currently lists 4 devices for Baoding Te'Anzhou Electronic Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Baoding Te'Anzhou Electronic Technology Co., Ltd.'s devices?
Among its 4 most recently registered devices, Baoding Te'Anzhou Electronic Technology Co., Ltd. has devices listed in EUDAMED (2 devices), FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Baoding Te'Anzhou Electronic Technology Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Baoding Te'Anzhou Electronic Technology Co., Ltd.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Baoding Te'Anzhou Electronic Technology Co., Ltd.?
EUDAMED lists 1 certificate for Baoding Te'Anzhou Electronic Technology Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-08-20.
What are the newest devices from Baoding Te'Anzhou Electronic Technology Co., Ltd. in the registry?
The most recently registered devices listed for Baoding Te'Anzhou Electronic Technology Co., Ltd. include Laser Surgery Instruments, Medical Diode Laser Systems (TR-B) and Medical Diode Laser Systems (VeinCure).
Which FDA establishments are linked to Baoding Te'Anzhou Electronic Technology Co., Ltd.?
1 FDA establishment is linked to Baoding Te'Anzhou Electronic Technology Co., Ltd. in the registry; they are listed on the company page.