Nanjing Perlove Medical Equipment Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000024840
- Devices
- 7
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Nanjing Perlove Medical Equipment Co., Ltd. makes
Nanjing Perlove Medical Equipment Co., Ltd. manufactures diagnostic X-ray systems, including the PLX5200A model, designed for medical imaging applications.
Their portfolio consists of Class II devices, authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Diagnostic X-ray System Ref PLX119C
Regimes: CE MDR Registry: EUDAMEDDiagnostic X-ray System Ref PLX5300A
Regimes: CE MDR Registry: EUDAMEDDiagnostic X-ray System Ref PLX5100
Regimes: CE MDR Registry: EUDAMEDDiagnostic X-ray System Ref PLX112B
Regimes: CE MDD Registry: EUDAMEDDiagnostic X-ray System Ref PLX118F
Regimes: CE MDR Registry: EUDAMEDDiagnostic X-ray System/PLX5200A Ref K212134
Regimes: 510(k) Registry: 510(k)Diagnostic X-ray System Ref K243411
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- CN-MF-000024840
- EUDAMED status
- Active
- EUDAMED registered name
- Nanjing Perlove Medical Equipment Co., Ltd.
- Registered address
- No. 97 and No. 99 Wangxi Road, Jiangning District, 211100, Nanjing, Jiangsu, China
- [email protected]
- PRRC contact
- Zhengwen Zhao
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 27 Sep 2030
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2027461-1 Active
Quality management system EU MDR
- Issued
- 28 Sep 2025
- Expires
- 27 Sep 2030
Frequently asked questions
How many devices does Nanjing Perlove Medical Equipment Co., Ltd. have in the registry?
The registry currently lists 7 devices for Nanjing Perlove Medical Equipment Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nanjing Perlove Medical Equipment Co., Ltd.'s devices?
Among its 7 most recently registered devices, Nanjing Perlove Medical Equipment Co., Ltd. has devices listed in EUDAMED (5 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Nanjing Perlove Medical Equipment Co., Ltd.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Nanjing Perlove Medical Equipment 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 Nanjing Perlove Medical Equipment Co., Ltd.?
EUDAMED lists 1 certificate for Nanjing Perlove Medical Equipment Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 28 Sep 2025.
What are the newest devices from Nanjing Perlove Medical Equipment Co., Ltd. in the registry?
The most recently registered devices listed for Nanjing Perlove Medical Equipment Co., Ltd. include Diagnostic X-ray System and Diagnostic X-ray System/PLX5200A.