PROMEBA Cervical Collar - Indonesia BPOM Medical Device Registration

PROMEBA Cervical Collar is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11402127106. The device is manufactured by PRODUCTOS METALICOS DEL BAGES, S.L. from Spain, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. PENTASADA SOLAR DYNAMICS.

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 : A

PROMEBA Cervical Collar

Analysis ID: AKL 11402127106

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Manufacturer

PRODUCTOS METALICOS DEL BAGES, S.L.

Country of Origin

Spain

Authorized Representative

PT. PENTASADA SOLAR DYNAMICS

AR Address

Jl. Menceng Raya No. 2 RT.003 RW.011 Kel. Tegal Alur Kec. Kalideres, Jakarta Barat 11820

Registration Date

Nov 19, 2021

Expiry Date

Sep 07, 2025

Product Type

Prosthetic Physical Health Equipment

Truncal orthosis.

Non Electromedic Non Sterile

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Other Products from PRODUCTOS METALICOS DEL BAGES, S.L.

Products from the same manufacturer (2 products)

PROMEBA Scoop Stretcher

Kelas Resiko : A

PROMEBA Head Immobilizer

Kelas Resiko : A

Other Products from PT. PENTASADA SOLAR DYNAMICS

Products with the same authorized representative (10 products)

PENTAMED Folding Scoop Stretcher

ZHANGJIAGANG TENGDA MACHINERY MANUFACTURER CO., LTD.

Kelas Resiko : A

Sunset Portable Suction Machine

VEGA TECHNOLOGIES INC.

Kelas Resiko : B

PENTAMED Spine Board

ZHANGJIAGANG TENGDA MACHINERY MANUFACTURER CO., LTD.

Kelas Resiko : A

PENTAMED ABS Scoop Stretcher

ZHANGJIAGANG TENGDA MACHINERY MANUFACTURER CO., LTD.

Kelas Resiko : A

PENTAMED Compact Folding Pole Stretcher

ZHANGJIAGANG TENGDA MACHINERY MANUFACTURER CO., LTD.

Kelas Resiko : A

PENTAMED Folding Pole Stretcher

ZHANGJIAGANG TENGDA MACHINERY MANUFACTURER CO., LTD.

Kelas Resiko : A

PENTAMED MLF999-C1 Rollo-Matic-H Full Automatic Stretcher with Removable Upper Stretcher

ZHANGJIAGANG TENGDA MACHINERY MANUFACTURER CO. LTD.

Kelas Resiko : B

PENTAMED Rollo-Glide Roll-in Cot Automatic Loading Stretcher

ZHANGJIAGANG TENGDA MACHINERY MANUFACTURER CO., LTD.

Kelas Resiko : B

PENTAMED Rollo-Cot Roll-in Chair Cot Automatic Loading Stretcher

ZHANGJIAGANG TENGDA MACHINERY MANUFACTURER CO., LTD.

Kelas Resiko : B

PROMEBA Air Splints

PRODUCTOS METALICOS DEL BAGES, S.L.,

Kelas Resiko : A