CELL-DYN Ruby and Accessories - Indonesia BPOM Medical Device Registration
CELL-DYN Ruby and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205310758. The device is manufactured by FLEXTRONICS MANUFACTURING (SINGAPORE) PTE., LTD. from Singapore, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
FLEXTRONICS MANUFACTURING (SINGAPORE) PTE., LTD.Country of Origin
Singapore
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Oct 23, 2023
Expiry Date
Sep 28, 2026
Product Type
Automatic and Semi-Automatic Hematology Equipment
Automated differential cell counter.
Invitro Diagnostics
ALINITY c Lactate Dehydrogenase2
ABBOTT IRELAND DIAGNOSTICS DIVISION
ARCHITECT Total T4 Reagent Kit
ABBOTT IRELAND DIAGNOSTICS DIVISION.
ALINITY c Amylase2
ABBOTT IRELAND DIAGNOSTICS DIVISION
ARCHITECT Consolidated Chemistry Calibrator
RANDOX LABORATORIES, LTD
ARCHITECT Total T4 Controls
ABBOTT IRELAND DIAGNOSTICS DIVISION.
MITRACLIP G4 NTW Clip Delivery System
ABBOTT MEDICAL (MENLO PARK)
ABBOTT Amylase2
ABBOTT IRELAND DIAGNOSTICS DIVISION.
MITRACLIP G4 Steerable Guide Catheter
ABBOTT MEDICAL. (Menlo park)
CELL-DYN Emerald 22 Diluent
AVANTOR PERFORMANCE MATERIALS S.A.
ALINITY hs Slide Maker Stainer Module and Accessories
SANMINA-SCI SYSTEMS SINGAPORE PTE LTD