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MENDEC Spine Kit - Indonesia BPOM Medical Device Registration

MENDEC Spine Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302220305. The device is manufactured by TECRES S.P.A. from Italy, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ENDO INDONESIA.

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
MENDEC Spine Kit
Analysis ID: AKL 21302220305

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

TECRES S.P.A.

Country of Origin

Italy

Authorized Representative

PT. ENDO INDONESIA

AR Address

Jl. Raya Menganti 14

Registration Date

Aug 11, 2022

Expiry Date

Dec 31, 2026

Product Type

Prosthetic Orthopedic Equipment

Polymethylmethacrylate (PMMA) bone cement.

Non Electromedic Sterile

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