Ultracare Diagnostics ANTI-D - Indonesia BPOM Medical Device Registration

Ultracare Diagnostics ANTI-D is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209320562. The device is manufactured by ULTRACARE CO., LTD. from Egypt, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is SAMUDERA INTI MEDISINDO.

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BPOM Registered

Risk Class Kelas Resiko : C

Ultracare Diagnostics ANTI-D

Analysis ID: AKL 20209320562

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

ULTRACARE CO., LTD.

Country of Origin

Egypt

Authorized Representative

SAMUDERA INTI MEDISINDO

AR Address

SAMUDERA INTI MEDISINDO

Registration Date

Aug 03, 2023

Expiry Date

Jan 30, 2027

Product Type

Products used in the manufacture of blood preparations and preparations of origin and blood

Automated blood grouping and antibody test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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