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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 21501520002. 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.

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BPOM Registered
Risk Class Kelas Resiko : C
3SHAPE Implant Studio
Analysis ID: AKL 21501520002

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

3SHAPE A/S

Country of Origin

Denmark

Authorized Representative

FONDACO JAYATAMA

AR Address

APL Tower Podomoro City Lantai 27 T1, T2, T5, Jln Letjen S. Parman Kavling 28

Registration Date

Jan 03, 2025

Expiry Date

Jan 25, 2028

Product Type

Diagnostic Radiology Equipment

Medical image management and processing system.

Non Radiation Electromedics

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