Wuxi Medical Instrument Factory
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000002277
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Wuxi Medical Instrument Factory makes
Wuxi Medical Instrument Factory manufactures disposable blood pressure cuffs designed for single-use clinical and home monitoring applications. These cuffs are intended for accurate measurement of systolic and diastolic blood pressure in adults and pediatric patients, adhering to standard sphygmomanometer compatibility.
The disposable blood pressure cuffs fall under FDA Class II regulation and are listed via the 510(k) pathway in the United States. The company operates within the regulatory framework of the US Food and Drug Administration.
Catalogue
Disposable Blood Pressure Cuff Ref K102823
Regimes: 510(k) Registry: 510(k)Farma+line Ref TER5171A
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000002277
- EU VAT number
- 91320205717438325D
- EUDAMED status
- Active
- EUDAMED registered name
- Wuxi Medical Instrument Factory Co.,Ltd.
- Registered address
- No. 43 Xixin Road,Zhangjing, Xibei Town,, 214194, Wuxi City, China
- [email protected]
- PRRC contact
- YANPING DING
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 28 Aug 2030
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2021367-1 Active
Quality management system EU MDR
- Issued
- 29 Aug 2025
- Expires
- 28 Aug 2030
Frequently asked questions
How many devices does Wuxi Medical Instrument Factory have in the registry?
The registry currently lists 2 devices for Wuxi Medical Instrument Factory. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wuxi Medical Instrument Factory's devices?
Among its 2 most recently registered devices, Wuxi Medical Instrument Factory has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Wuxi Medical Instrument Factory's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Wuxi Medical Instrument Factory's devices are Class I and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Wuxi Medical Instrument Factory?
EUDAMED lists 1 certificate for Wuxi Medical Instrument Factory (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 29 Aug 2025.
What are the newest devices from Wuxi Medical Instrument Factory in the registry?
The most recently registered devices listed for Wuxi Medical Instrument Factory include DISPOSABLE BLOOD PRESSURE CUFF and FARMA+LINE.