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STI Otoscope - Indonesia BPOM Medical Device Registration

STI Otoscope is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20801220006. The device is manufactured by TIANJIN BOLANG SCIENCE-TECHNOLOGY DEVELOPMENT CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SOMETECH NEW Zealand.

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
STI Otoscope
Analysis ID: AKL 20801220006

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. SOMETECH NEW Zealand

AR Address

AKR Tower Lantai 11 Unit 11G dan 11C, Jalan Panjang Nomor 5 ,RT 011 RW 010, Kec. Kebon Jeruk, Kel. Kebon Jeruk, Jakarta Barat, 11530

Registration Date

Nov 22, 2024

Expiry Date

Nov 21, 2027

Product Type

Diagnostic Gastroenterology-Urology Equipment

Endoscope and accessories.

Non Electromedic Non Sterile

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