Pure Global

3SHAPE Implant Studio - Indonesia BPOM Medical Device Registration

3SHAPE Implant Studio is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602128934. The device is manufactured by 3SHAPE MEDICAL A/S from Denmark, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FONDACO JAYATAMA.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
3SHAPE Implant Studio
Analysis ID: AKL 20602128934

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

3SHAPE MEDICAL A/S

Country of Origin

Denmark

Authorized Representative

PT. FONDACO JAYATAMA

AR Address

Agung Podomoro Land Tower, Podomoro City Lt. 27 T1, T2, T5 Jl. Letnan Jendral Siswondo Parman Kav. 28 Kel. Tanjung Duren Selatan, Kec. Grogol Petamburan, Jakarta Barat, DKI Jakarta

Registration Date

Dec 31, 2021

Expiry Date

Aug 31, 2024

Product Type

Prosthetic Dental Equipment

Optical Impression Systems for CAD/CAM.

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing