SMARTONE Handles - Indonesia BPOM Medical Device Registration
SMARTONE Handles is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603126692. The device is manufactured by ZHEJIANG MEDSTAR TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. TAWADA HEALTHCARE.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
ZHEJIANG MEDSTAR TECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. TAWADA HEALTHCAREAR Address
Rukan Permata Senayan Blok A18-19 Lantai 1-2 Jl. Tentara Pelajar No. 5
Registration Date
Mar 16, 2023
Expiry Date
Aug 15, 2025
Product Type
Surgical Equipment
Electrosurgical cutting and coagulation device and accessories.
Non Electromedic Sterile
QUANTUM 2 (RF 12000)
SMITH & NEPHEW INC, ENDOSCOPY DIVISION
QUARTETโข Left Heart Lead
ABBOTT MEDICAL
ISOFLEX Lead
ABBOTT MEDICAL
SMITH & NEPHEW Fast Fix Instruments
ARTHROCARE CORPORATION
TWINFIX Ti Suture Anchors
ARTHROCARE CORPORATION
QUICKFLEXโข ยต Left Heart Lead
ABBOTT MEDICAL
HAETMED Small Steam Sterilizer
HAETMED (WUXI) CO., LTD.
SMITH & NEPHEW Genesis II Instrument
STRAITS ORTHOPAEDICS (MFG) SDN., BHD.
HAETMED Small Steam Sterilizer
HAETMED (WUXI) CO., LTD.
HAETMED Small Steam Sterilizer
HAETMED (WUXI) CO., LTD.

