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DOLPHIN Laminoplasty System - Indonesia BPOM Medical Device Registration

DOLPHIN Laminoplasty System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302320642. The device is manufactured by TDM CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FAJAR SELARAS PARTNERS.

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BPOM Registered
Risk Class Kelas Resiko : C
DOLPHIN Laminoplasty System
Analysis ID: AKL 21302320642

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

TDM CO., LTD.

Country of Origin

Korea

Authorized Representative

PT. FAJAR SELARAS PARTNERS

AR Address

Komplek Rukan PTC Blok 8C No. 28-29 Pulogadung Tel. 021-46827776 Fax. 021-46827033

Registration Date

Apr 26, 2023

Expiry Date

Sep 30, 2025

Product Type

Prosthetic Orthopedic Equipment

Single/multiple component metallic bone fixation appliances and accessories.

Non Electromedic Non Sterile

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