Guangzhou Shengwei Medical Devices Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000036471 FEI 3015665020
- Devices
- 3
- 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 FEI
- Authorised rep.
- MedPath GmbHDE
Catalogue
Surgical Skin Marker Ref Dual tip
Regimes: CE MDR Registry: EUDAMED- Regimes: 510(k) Registry: 510(k)
Surgical Skin Marker Ref Regular tip
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000036471
- FDA FEI number
- 3015665020
- EUDAMED status
- Active
- EUDAMED registered name
- Guangzhou Shengwei Medical Devices Co., Ltd.
- Registered address
- No.126, Guangshao Road, Aotou Town, Conghua District, 510945, Guangzhou, Guangdong Province, China
- [email protected]
- PRRC contact
- Jian Li
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 10 Apr 2031
Intertek Medical Notified Body AB 2862 1 certificate
- 28620259906 Active
Quality management system EU MDR
- Issued
- 22 Oct 2026
- Expires
- 10 Apr 2031
Frequently asked questions
How many devices does Guangzhou Shengwei Medical Devices Co., Ltd. have in the registry?
The registry currently lists 3 devices for Guangzhou Shengwei Medical Devices Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Guangzhou Shengwei Medical Devices Co., Ltd.'s devices?
Among its 3 most recently registered devices, Guangzhou Shengwei Medical Devices Co., Ltd. has devices listed in EUDAMED (2 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Guangzhou Shengwei Medical Devices Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Guangzhou Shengwei Medical Devices Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Guangzhou Shengwei Medical Devices Co., Ltd.?
EUDAMED lists 1 certificate for Guangzhou Shengwei Medical Devices Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 22 Oct 2026.
What are the newest devices from Guangzhou Shengwei Medical Devices Co., Ltd. in the registry?
The most recently registered devices listed for Guangzhou Shengwei Medical Devices Co., Ltd. include Surgical Skin Marker and Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle.