HETTICH Rotixa 500 RS and Accessories - Indonesia BPOM Medical Device Registration

HETTICH Rotixa 500 RS and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102020496. The device is manufactured by ANDREAS HETTICH GMBH & CO., KG. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PRIMA ALKESINDO NUSANTARA.

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 : B

HETTICH Rotixa 500 RS and Accessories

Analysis ID: AKL 20102020496

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

ANDREAS HETTICH GMBH & CO., KG.

Country of Origin

Germany

Authorized Representative

PRIMA ALKESINDO NUSANTARA

AR Address

Jl. Bukit Gading Raya Blok C 12 - C 15 Kel. Kelapa Gading Barat, Kec. Kelapa Gading, Jakarta Utara

Registration Date

Mar 22, 2024

Expiry Date

Jan 25, 2029

Product Type

Clinical Laboratory Equipment

Centrifugal chemistry analyzer for clinical use

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Other Products from ANDREAS HETTICH GMBH & CO., KG.

Products from the same manufacturer (2 products)

HETTICH Microlitre Centrifuge Mikro 185 and Accessories

Kelas Resiko : B

HETTICH Haematokrit 200 and Accessories

Kelas Resiko : B

Other Products from PRIMA ALKESINDO NUSANTARA

Products with the same authorized representative (10 products)

OBG Forward and Reverse Grouping

ISLAB BIOTECHNOLOGY MEDICAL MATERIAL HEALTH SPEED. SAN. VE TIC. A.S.

Kelas Resiko : C

ODAK OBG CELL SCREEN 1-2-3

ISLAB BIOTECHNOLOGY MEDICAL MATERIAL HEALTH SPEED. SAN. VE TIC. A.S.

Kelas Resiko : C

ODAK OBG CELL ID 11

ISLAB BIOTECHNOLOGY MEDICAL MATERIAL HEALTH SPEED. SAN. VE TIC. A.S.

Kelas Resiko : C

ODAK OBG LISS DILUENT

ISLAB BIOTECHNOLOGY MEDICAL MATERIAL HEALTH SPEED. SAN. VE TIC. A.S.

Kelas Resiko : C

ODAK Gel Card Centrifuge

ISLAB BIOTECHNOLOGY MEDICAL MATERIAL HEALTH SPEED. SAN. VE TIC. A.S.

Kelas Resiko : C

ODAK Gel Card Centrifuge

ISLAB BIOTECHNOLOGY MEDICAL MATERIAL HEALTH SPEED. SAN. VE TIC. A.S.

Kelas Resiko : C

ODAK GEL CARD INCUBATOR

ISLAB BIOTECHNOLOGY MEDICAL MATERIAL HEALTH SPEED. SAN. VE TIC. A.S.

Kelas Resiko : C

KIRSCH Blood Bank Freezer

PHILIPP KIRSCH GMBH

Kelas Resiko : B

KIRSCH Blood Bank Refrigerator

PHILIPP KIRSCH GMBH

Kelas Resiko : B

KIRSCH Blood Bank Freezer

PHILIPP KIRSCH GMBH

Kelas Resiko : B