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WONDFO IgE (CLIA) - Indonesia BPOM Medical Device Registration

WONDFO IgE (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305420589. The device is manufactured by SHENZEN TISENC MEDICAL DEVICES CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ZOE PELITA 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.

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BPOM Registered
Risk Class Kelas Resiko : B
WONDFO IgE (CLIA)
Analysis ID: AKL 20305420589

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. ZOE PELITA NUSANTARA

AR Address

JALAN CIKINI II NO 8 B

Registration Date

Nov 22, 2024

Expiry Date

Aug 01, 2028

Product Type

Immunological Test System

Immunoglobulins A, G, M, D, and E immunological test system.

Invitro Diagnostics

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