TSKGEL GX - Indonesia BPOM Medical Device Registration
TSKGEL GX is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207910600. The device is manufactured by TOSOH HI-TECH, INC. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. KARINDO ALKESTRON.
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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
TOSOH HI-TECH, INC.Country of Origin
Japan
Authorized Representative
PT. KARINDO ALKESTRONAR Address
JL. TOMANG RAYA NO.17
Registration Date
Jul 11, 2023
Expiry Date
Jun 30, 2027
Product Type
Haematology Package and Kit
Glycosylated hemoglobin assay.
Invitro Diagnostics
TOSOH G11 B-THALASSEMIA ELUTION BUFFER NO. 3 (S)
TOSOH G11 ฮฒ -Thalassemia Elution Buffer No. 2 (S)
TOSOH G11 F&A2 Control Set
TOSOH TSKgel G11 B-Thal
TOSOH G11 ฮฒ-Thalassemia Elution Buffer No. 1 (S)
TOSOH TSKgel G11 VARIANT
TOSOH G11 Variant Elution Buffer No. 3 (S)
TOSOH G11 Variant Elution Buffer No. 2 (S)
TOSOH G11 VARIANT ELUTION BUFFER No. 1 (S)
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TOSOH ST AIA-PACK HBeAg
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TOSOH ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION
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TOSOH ST AIA-PACK Myoglobin
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