DRAP REGISTERED MEDICAL DEVICE
Zybio Hemoglobin A1c Assay Kit is registered with DRAP under number MDIR-0008439 as a Class B (low to moderate risk) medical device, imported. The listed holder is Zybio Medical Pakistan (SMC-Private) Limited. It is listed as valid until 3 Apr 2030.
Screening result
MDIR-0008439 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
That list covers manually issued licences only. Ask for a copy of the establishment licence.
| Device | Zybio Hemoglobin A1c Assay Kit |
|---|---|
| Class | B |
| Listed holder | Zybio Medical Pakistan (SMC-Private) Limited |
| Holder address | House No 323, Street No. 66, Sector I-8/3, Islamabad |
| Manufacturing site | M/s Zybio Inc. Floor 1 to floor 5, building 30, No.6 of taikang road, block C of Jianqiao Industrial Par, Daduko District, 400082 Chongqing, PEOPLES’S REPUBLIC OF CHINA |
| Issued | 4 Apr 2025 |
| Renewal date | 3 Apr 2030 |
Specifications
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Screened 6 Oct 2026, 17:32 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
Other DRAP registrations and enlistments listed for the same company.
| MDIE-0001601 | Zybio Diluent | Class A |
| MDIE-0001602 | Zybio Probe cleanser | Class A |
| MDIE-0001603 | Zybio Hematology Analyzer | Class A |
| MDIE-0002070 | ZYBIO Chemistry Analyzer [EXC200 EXC220] | Class A |
| MDIE-0002071 | ZYBIO Diluent kit [20 Lx1 Bucket, 10 Lx1 bucket | Class A |
| MDIE-0002072 | ZYBIO Lyse kit [250mL/ Bottle 500mL/ Bottle] | Class A |
| MDIE-0002073 | ZYBIO Lyse kit [Z5 LD) 500mL x 1] | Class A |
| MDIE-0002074 | ZYBIO Nucleic Acid Isolation System [EXM3000] | Class A |
| MDIE-0002075 | ZYBIO Nucleic Acid Isolation System [EXM6000] | Class A |
| MDIE-0002076 | ZYBIO Blood Culture Bottle (Colorimetric Method) - Resin Anaerobic Bottle (AN) [20 Bottles/box 100 bottles/box] | Class A |
| MDIR-0006502 | ZYBIO (PCT Asaay CLIA) [1x50T/Kit, 2x50T/Kit, 1x100T/Kit, 2x100T/Kit] | Class C |
| MDIR-0006503 | ZYBIO (NT-proBNP Assay immunofluroscence) [25T/kit] | Class C |
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.