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PT. PURE SOUTHEAST ASIA INDONESIA
Authorized Representative in Indonesia
Equity Tower, 26th Floor H, Kav
52-53, Jl. Jenderal Sudirman
9 Products Represented
7 Manufacturers
Total Products
9
Manufacturers
7
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
1 products11.1%
Kelas Resiko : B
5 products55.6%
Kelas Resiko : C
2 products22.2%
Kelas Resiko : D
1 products11.1%
Manufacturer Portfolio
Products organized by manufacturer
3 Products
1 Products
1 Products
1 Products
1 Products
1 Products
All Represented Products (9)
Complete portfolio registered with BPOM
DRAGONFLY™ Transcatheter Mitral Valve Repair System and Accessories
Manufacturer:
HANGZHOU VALGEN MEDTECH CO., LTD.
Class:
Kelas : 3
Risk Class:
Kelas Resiko : D
Registration Date:
Feb 6, 2025
WEIREN Ophthalmic Optical Coherence Tomography System
Manufacturer:
GUANGDONG WEIREN MEDITECH CO., LTD.
Class:
Kelas : 2
Risk Class:
Kelas Resiko : B
Registration Date:
Jan 3, 2025
NUOYUAN 4K FLI-20E Endoscopic Fluorescent Imaging System
Manufacturer:
NANJING NUOYUAN MEDICAL DEVICES CO., LTD.
Class:
Kelas : 2
Risk Class:
Kelas Resiko : B
Registration Date:
Jan 3, 2025
CURAWAY Semi-Automatic Core Biopsy Instruments
Manufacturer:
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
Class:
Kelas : 1
Risk Class:
Kelas Resiko : A
Registration Date:
Dec 22, 2024
YUANHUA Robotic Orthopaedic Surgical Systems
Manufacturer:
YUANHUA ORTHOPAEDIC ROBOTICS (SHENZHEN) CO., LTD.
Class:
Kelas : 2
Risk Class:
Kelas Resiko : C
Registration Date:
Oct 15, 2024
SAFECARE Multi-Drug Urine Test Dip Card 6 in 1 (AMP1000/COC300/THC50/BZO300/MET1000/MOP (Opiat)300)
Manufacturer:
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Class:
Kelas : 2
Risk Class:
Kelas Resiko : C
Registration Date:
Oct 11, 2024
WEIREN Ophthalmic Optical Coherence Tomography System
Manufacturer:
GUANGDONG WEIREN MEDITECH CO., LTD.
Class:
Kelas : 2
Risk Class:
Kelas Resiko : B
Registration Date:
Oct 11, 2024
WEIREN Ophthalmic Optical Coherence Tomography System
Manufacturer:
GUANGDONG WEIREN MEDITECH CO., LTD.
Class:
Kelas : 2
Risk Class:
Kelas Resiko : B
Registration Date:
Oct 11, 2024
EDGE Endoscopic Instrument Control System
Manufacturer:
SHENZHEN EDGE MEDICAL CO., LTD.
Class:
Kelas : 2
Risk Class:
Kelas Resiko : B
Registration Date:
Aug 9, 2024
Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.
Last updated: December 2025