Nanjing Shuangwei Biotechnology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000023311 FEI 3008516548
- Devices
- 9
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Shanghai International Holding Corp. GmbH(Europe)DE
What Nanjing Shuangwei Biotechnology Co., Ltd. makes
The company manufactures leukocyte reduction filters designed for blood processing, including both standalone filters and those integrated for blood collection systems. These devices are intended to remove leukocytes from blood components to reduce transfusion-related complications.
The portfolio consists of Class IIb medical devices listed in the EUDAMED registry, reflecting compliance with EU regulatory requirements. The company is based in China.
Catalogue
Leukocyte Reduction Filter for Blood Ref FTS-RC302
Regimes: CE MDR Registry: EUDAMEDLeukocyte Reduction Filter Ref LF-RC201
Regimes: CE MDR Registry: EUDAMEDLeukocyte Reduction Filter for Blood Ref FTS-PL110
Regimes: CE MDR Registry: EUDAMEDLeukocyte Reduction Filter Ref LF-PL110
Regimes: CE MDR Registry: EUDAMEDLeukocyte Reduction Filter for Blood Ref FTS-RC200
Regimes: CE MDR Registry: EUDAMEDLeukocyte Reduction Filter for Blood Ref FTS-RC202
Regimes: CE MDR Registry: EUDAMEDLeukocyte Reduction Filter for Blood Ref FTS-RC300
Regimes: CE MDR Registry: EUDAMEDLeukocyte Reduction Filter Ref LF-PL210
Regimes: CE MDR Registry: EUDAMEDLeukocyte Reduction Filter Ref LF-RC101
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000023311
- FDA FEI number
- 3008516548
- EUDAMED status
- Active
- EUDAMED registered name
- Nanjing Shuangwei Biotechnology Co., Ltd.
- EUDAMED abbreviated name
- Shuangwei
- Registered address
- No.123, Huakang Road, Jiangbei New Area,, 210000, Nanjing, Jiangsu, China
- Website
- http//:www.shuangweibiotech.com
- [email protected]
- Phone
- +86-25-58842973
- PRRC contact
- Weichao Pan
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 9 Jan 2029
TÜV SÜD Product Service GmbH 0123 1 certificate
- G10 109472 0004 Active
Quality management system EU MDR
- Issued
- 10 Jan 2024
- Expires
- 9 Jan 2029
Frequently asked questions
How many devices does Nanjing Shuangwei Biotechnology Co., Ltd. have in the registry?
The registry currently lists 9 devices for Nanjing Shuangwei Biotechnology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nanjing Shuangwei Biotechnology Co., Ltd.'s devices?
Among its 9 most recently registered devices, Nanjing Shuangwei Biotechnology Co., Ltd. has devices listed in EUDAMED (9 devices).
What risk classes do Nanjing Shuangwei Biotechnology Co., Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Nanjing Shuangwei Biotechnology Co., Ltd.'s devices are Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Nanjing Shuangwei Biotechnology Co., Ltd.?
EUDAMED lists 1 certificate for Nanjing Shuangwei Biotechnology Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 10 Jan 2024.
What are the newest devices from Nanjing Shuangwei Biotechnology Co., Ltd. in the registry?
The most recently registered devices listed for Nanjing Shuangwei Biotechnology Co., Ltd. include Leukocyte Reduction Filter for Blood and Leukocyte Reduction Filter.