SIMAI CO., LTD.

China CN-MF-000021302 Last updated 8 Jun 2026

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Devices: 4
Registries: EUDAMED
FDA recalls: 0

Catalogue4

Plasma Bipolar Resection Generator Ref SM20CH

Class IIb EUDAMED Active
Single use Sterile Plasma Bipolar Electrode Ref SM01-001A...43 models total

Class IIb EUDAMED Active
Non-streile Resectoscope Ref SMNKJ

Class IIa EUDAMED Active
Morcellator System Ref SPS-600

Class IIb EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

Notified body 1639 1 certificate

CN26/00004812 Issued

Quality management system EU MDR

Issued
1 Jul 2026

Expires
1 Jun 2031

Authorised representatives

Wellkang Ltd XI

Notified bodies

Notified body 1639

Information

Country: China
Address: 1-5th Floor,Building 15, Tsinghua Science Park, No.101, College RD, Tangjia, Zhuhai, China
Website: scanmed-cn.com
Email: [email protected]
Phone: +86 756 3612518
PRRC contact: YuanYuan Lin
EUDAMED SRN: CN-MF-000021302