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ORTOLUX TOP Artificial Teeth - Indonesia BPOM Medical Device Registration

ORTOLUX TOP Artificial Teeth is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602901617. The device is manufactured by UNION DENTAL S.A. from Spain, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is THOMASONG NIRMALA.

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
ORTOLUX TOP Artificial Teeth
Analysis ID: AKL 20602901617

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

UNION DENTAL S.A.

Country of Origin

Spain

Authorized Representative

THOMASONG NIRMALA

AR Address

JL. AM SANGAJI NO. 20A KEL. PETOJO UTARA, KEC. GAMBIR JAKARTA TELP. 021-63855888

Registration Date

Feb 16, 2023

Expiry Date

Dec 08, 2027

Product Type

Prosthetic Dental Equipment

Preformed plastic denture tooth.

Non Electromedic Non Sterile

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