Pure Global

PINNACLE BIOLOX Delta Ceramax Ceramic Insert - Indonesia BPOM Medical Device Registration

PINNACLE BIOLOX Delta Ceramax Ceramic Insert is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302320872. The device is manufactured by CERAMTEC GMBH from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is JOHNSON AND JOHNSON INDONESIA TWO.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : C
PINNACLE BIOLOX Delta Ceramax Ceramic Insert
Analysis ID: AKL 21302320872

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

CERAMTEC GMBH

Country of Origin

Germany

Authorized Representative

JOHNSON AND JOHNSON INDONESIA TWO

AR Address

K-Link Tower, Lt. 15, Jl. Jend. Gatot Subroto kav. 59A, Kuningan, Setiabudi, Jakarta Selatan, Desa/Kelurahan Kuningan Timur, Kec. Setiabudi, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12950

Registration Date

Sep 07, 2023

Expiry Date

Feb 21, 2028

Product Type

Prosthetic Orthopedic Equipment

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

Non Electromedic Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing