Xiantao sanda industrial CO., LTD
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000028098
- Devices
- 24
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
0 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
- Authorised rep.
- SUNGO Europe B.V.NL
Catalogue
Disposable surgical pack Ref SDP006
Surgical Face Mask Ref K222651
Disposable surgical pack Ref SDP010
Disposable surgical pack Ref SDP008
Disposable surgical pack Ref SDP001
Disposable surgical pack Ref SDP005
Disposable surgical pack Ref SDP004
Disposable surgical pack Ref SDP012
Disposable surgical pack Ref SDP002
Disposable surgical pack Ref SDP009
Company details
- EUDAMED SRN
- CN-MF-000028098
- EUDAMED status
- Active
- EUDAMED registered name
- Xiantao sanda industrial CO.,LTD
- Registered address
- No. 46,East Of Golden Avenue,, 433000, Xiantao,Hubei, China
- [email protected]
- PRRC contact
- Leo Hu
EUDAMED certificates
1 certificate0 valid, 0 expired, 1 withdrawn or suspendedMDR 1
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2416875-1 Cancelled
Quality management system EU MDR
- Issued
- 24 Apr 2024
- Expires
- 23 Apr 2029
- Reason
- Other
FDA establishments
- Xiantao Sanda Industrial Co., Ltd. US
What Xiantao sanda industrial CO., LTD makes
Xiantao Sanda Industrial Co., Ltd manufactures single-use protective and surgical apparel, including patient gowns, isolation gowns, surgical gowns, and coveralls. Their portfolio also covers disposable surgical packs, medical gloves, face masks, and shoe covers, designed for medical and clinical environments.
These products are classified as Class I medical devices and are listed in the EU’s eudamed registry. The company is based in China.
Frequently asked questions
How many devices does Xiantao sanda industrial CO.,LTD have in the registry?
The registry currently lists 24 devices for Xiantao sanda industrial CO.,LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xiantao sanda industrial CO.,LTD's devices?
Among its 24 most recently registered devices, Xiantao sanda industrial CO.,LTD has devices listed in EUDAMED (23 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 Xiantao sanda industrial CO.,LTD's devices fall under?
Among its 24 most recently registered devices, the classes recorded for Xiantao sanda industrial 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 Xiantao sanda industrial CO.,LTD?
EUDAMED lists 1 certificate for Xiantao sanda industrial CO.,LTD (quality management system) under MDR. The most recent was issued on 2024-04-24.
What are the newest devices from Xiantao sanda industrial CO.,LTD in the registry?
The most recently registered devices listed for Xiantao sanda industrial CO.,LTD include Patient Gown, Isolation Gown, Disposable surgical pack and Surgical Face Mask.
Which FDA establishments are linked to Xiantao sanda industrial CO.,LTD?
1 FDA establishment is linked to Xiantao sanda industrial CO.,LTD in the registry; they are listed on the company page.