Sichuan Nigale Biotechnology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000015825
- Devices
- 25
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- Authorised rep.
- Shanghai International Holding Corp. GmbH(Europe)DE
Catalogue
Blood Cell Processor Ref 04
Plasma Separator Ref 04
Blood Component Separator Ref 04
Plasma Separator Ref 04
Company details
- EUDAMED SRN
- CN-MF-000015825
- EUDAMED status
- Active
- EUDAMED registered name
- Sichuan Nigale Biotechnology Co., Ltd.
- Registered address
- No.28, No.28 Kuixing Road, 641400, Jianyang, Sichuan, China
- [email protected]
- PRRC contact
- Jinfeng Shen
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 20 Sep 2031
TÜV SÜD Product Service GmbH 0123 1 certificate
- G15 067972 0013 Issued
Quality management system EU MDR
- Issued
- 21 Sep 2026
- Expires
- 20 Sep 2031
What Sichuan Nigale Biotechnology Co., Ltd. makes
The company manufactures medical devices for blood component separation, including plasma separators and disposable apheresis sets designed for plasma and blood component collection. These devices are used in therapeutic apheresis procedures to extract plasma or specific blood components from donors. The portfolio also includes blood component separators for automated processing of blood products in clinical settings.
The devices fall under EU regulatory classifications of Class IIa and Class IIb, indicating moderate to high risk, and are registered in the EU’s medical device database, eudamed. The company is based in China and adheres to relevant regulatory standards for these device categories.
Frequently asked questions
How many devices does Sichuan Nigale Biotechnology Co., Ltd. have in the registry?
The registry currently lists 25 devices for Sichuan Nigale Biotechnology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sichuan Nigale Biotechnology Co., Ltd.'s devices?
Among its 25 most recently registered devices, Sichuan Nigale Biotechnology Co., Ltd. has devices listed in EUDAMED (25 devices).
What risk classes do Sichuan Nigale Biotechnology Co., Ltd.'s devices fall under?
Among its 25 most recently registered devices, the classes recorded for Sichuan Nigale Biotechnology Co., Ltd.'s devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Sichuan Nigale Biotechnology Co., Ltd.?
EUDAMED lists 1 certificate for Sichuan Nigale Biotechnology Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-09-21.
What are the newest devices from Sichuan Nigale Biotechnology Co., Ltd. in the registry?
The most recently registered devices listed for Sichuan Nigale Biotechnology Co., Ltd. include Blood Cell Processor, Plasma Separator, Disposable Plasma Apheresis Set and Disposable Blood Component Apheresis Set.