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3Shape Splint Design - Indonesia BPOM Medical Device Registration

3Shape Splint Design is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501420002. The device is manufactured by 3SHAPE A/S from Denmark, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is 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.

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BPOM Registered
Risk Class Kelas Resiko : C
3Shape Splint Design
Analysis ID: AKL 21501420002

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

3SHAPE A/S

Country of Origin

Denmark

Authorized Representative

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

Jan 03, 2024

Expiry Date

Jan 25, 2028

Product Type

Diagnostic Radiology Equipment

Medical image management and processing system.

Non Radiation Electromedics

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