Shenzhen MedRena Biotech Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000026006
- Devices
- 4
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- Authorised rep.
- SUNGO Europe B.V.NL
What Shenzhen MedRena Biotech Co., Ltd. makes
Shenzhen MedRena Biotech Co., Ltd. manufactures infusion pumps designed for controlled administration of fluids and medications in clinical settings. These devices are engineered to deliver precise dosing and monitoring for intravenous therapies, including chemotherapy, parenteral nutrition, and pain management solutions. Their products are intended for both hospital and ambulatory care environments to ensure accurate and safe medication delivery.
The company’s infusion pumps fall under Class IIb regulatory classification in the EU, requiring conformity assessment procedures to ensure safety and performance. These devices are registered in the EUDAMED database, adhering to EU Medical Device Regulations (MDR). The manufacturer operates from Shenzhen, China.
Catalogue
Infusion Pump Ref VP90
Regimes: CE MDR Registry: EUDAMEDInfusion pump Ref VP90 Neo
Regimes: CE MDR Registry: EUDAMEDInfusion Pump Ref VP50 Pro
Regimes: CE MDR CE MDD Registry: EUDAMEDInfusion Pump Ref VP50
Regimes: CE MDD Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000026006
- EUDAMED status
- Active
- EUDAMED registered name
- Shenzhen MedRena Biotech Co.,Ltd.
- Registered address
- 801,901, 1001, Building 4, YESUN Life and Health Technology Park, No. 19 Linhui Road, Jinsha Community, Kengzi Street, Pingshan District, Shenzhen, 518122 , Guangdong, P.R. China, 518122, Shenzhen, China
- [email protected]
- PRRC contact
- Hongjie Xie
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 19 May 2031
IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. 0051 1 certificate
- 285/MDR Active
Quality management system EU MDR
- Issued
- 20 May 2026
- Expires
- 19 May 2031
Frequently asked questions
How many devices does Shenzhen MedRena Biotech Co., Ltd. have in the registry?
The registry currently lists 4 devices for Shenzhen MedRena Biotech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen MedRena Biotech Co., Ltd.'s devices?
Among its 4 most recently registered devices, Shenzhen MedRena Biotech Co., Ltd. has devices listed in EUDAMED (4 devices).
What risk classes do Shenzhen MedRena Biotech Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Shenzhen MedRena Biotech Co., Ltd.'s devices are Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Shenzhen MedRena Biotech Co., Ltd.?
EUDAMED lists 1 certificate for Shenzhen MedRena Biotech Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 20 May 2026.
What are the newest devices from Shenzhen MedRena Biotech Co., Ltd. in the registry?
The most recently registered devices listed for Shenzhen MedRena Biotech Co., Ltd. include Infusion Pump.