Shandong Wego Ruisheng Medical Device Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000043800
- Devices
- 8
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Shandong Wego Ruisheng Medical Device Co., Ltd. makes
The company manufactures cryopreservation accessories for reproductive and biological samples, including cryo-straws for storage, warming kits (4 mL and 8 mL volumes), and vitrification kits (3 mL and 6 mL volumes). These products are designed for controlled freezing and thawing of sperm, embryos, or other biological materials.
The portfolio consists of Class II medical devices listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
lVF Embryo Transfer Catheter Ref WG Ⅱ
Regimes: CE MDR Registry: EUDAMEDlVF Embryo Transfer Catheter Ref WG Ⅳ
Regimes: CE MDR Registry: EUDAMEDOocyte Pick-up Needle Ref WG Ⅰ 17
Regimes: CE MDR Registry: EUDAMEDlVF Embryo Transfer Catheter Ref WG Ⅴ
Regimes: CE MDR Registry: EUDAMEDlVF Embryo Transfer Catheter Ref WG Ⅲ
Regimes: CE MDR Registry: EUDAMEDOocyte Pick-up Needle Ref WG Ⅱ 17
Regimes: CE MDR Registry: EUDAMEDIVF Embryo Transfer Catheter Ref WG Ⅰ
Regimes: CE MDR Registry: EUDAMEDCryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) Ref K233477
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- CN-MF-000043800
- EU VAT number
- 91371000MA3WL3RG7K
- EUDAMED status
- Active
- EUDAMED registered name
- Shandong Wego Ruisheng Medical Device Co.,Ltd
- Registered address
- No.1, Weigao Road Torch High-Tech Industrial Development Zone, 264210, Weihai，Shandong, China
- [email protected]
- Phone
- +86 631 5715912
- PRRC contact
- yan tian
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 28 May 2030
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 811380 Active
Quality management system EU MDR
- Issued
- 29 May 2025
- Expires
- 28 May 2030
Frequently asked questions
How many devices does Shandong Wego Ruisheng Medical Device Co., Ltd. have in the registry?
The registry currently lists 8 devices for Shandong Wego Ruisheng Medical Device Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shandong Wego Ruisheng Medical Device Co., Ltd.'s devices?
Among its 8 most recently registered devices, Shandong Wego Ruisheng Medical Device Co., Ltd. has devices listed in EUDAMED (7 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Shandong Wego Ruisheng Medical Device Co., Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Shandong Wego Ruisheng Medical Device Co., Ltd.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Shandong Wego Ruisheng Medical Device Co., Ltd.?
EUDAMED lists 1 certificate for Shandong Wego Ruisheng Medical Device Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 29 May 2025.
What are the newest devices from Shandong Wego Ruisheng Medical Device Co., Ltd. in the registry?
The most recently registered devices listed for Shandong Wego Ruisheng Medical Device Co., Ltd. include lVF Embryo Transfer Catheter, Oocyte Pick-up Needle, IVF Embryo Transfer Catheter and Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML).