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3SHAPE Lab Scanner System - Indonesia BPOM Medical Device Registration

3SHAPE Lab Scanner System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602420291. The device is manufactured by 3SHAPE POLAND SP. Z O. O. from Poland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FONDACO JAYATAMA.

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BPOM Registered
Risk Class Kelas Resiko : B
3SHAPE Lab Scanner System
Analysis ID: AKL 20602420291

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Poland

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

Jul 11, 2024

Expiry Date

Apr 03, 2029

Product Type

Prosthetic Dental Equipment

Optical Impression Systems for CAD/CAM.

Non Radiation Electromedics

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