ZYBIO Nucleic Acid Isolation System [EXM3000] - DRAP MDIE-0002074 (Class A)

DRAP ENLISTED MEDICAL DEVICE

ZYBIO Nucleic Acid Isolation System [EXM3000] is enlisted with DRAP under number MDIE-0002074 as a Class A (low risk) medical device, imported. The listed holder is Zybio Medical Pakistan (SMC-Private) Limited. It is listed as valid until 18 Jul 2030.

Screening result

i
Imported device, enlisted with DRAP as Class A (low risk)
MDIE-0002074 · the class is taken from DRAP's list for this number
✓
Found in DRAP's published list
DRAP enlisted Class A list, 28 Aug 2025
✓
Listed valid until 18 Jul 2030
i
Holder not found in DRAP's published licence list
That list covers manually issued licences only. Ask for a copy of the establishment licence.
DeviceZYBIO Nucleic Acid Isolation System [EXM3000]
ClassA
Listed holderZybio Medical Pakistan (SMC-Private) Limited
Holder addressHouse No 323, Street No. 66, Sector I-8/3, Islamabad
Manufacturing siteM/s Zybio Inc No. 45, Shilin Avenue, Tiaodeng Town, Dadukou District, 400082 Chongqing, People's Republic of China
Issued19 Jul 2025
Renewal date18 Jul 2030

Specifications

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Screened 5 Oct 2026, 13:16 (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-0001601Zybio DiluentClass A
MDIE-0001602Zybio Probe cleanserClass A
MDIE-0001603Zybio Hematology AnalyzerClass A
MDIE-0002070ZYBIO Chemistry Analyzer [EXC200 EXC220]Class A
MDIE-0002071ZYBIO Diluent kit [20 Lx1 Bucket, 10 Lx1 bucketClass A
MDIE-0002072ZYBIO Lyse kit [250mL/ Bottle 500mL/ Bottle]Class A
MDIE-0002073ZYBIO Lyse kit [Z5 LD) 500mL x 1]Class A
MDIE-0002075ZYBIO Nucleic Acid Isolation System [EXM6000]Class A
MDIE-0002076ZYBIO Blood Culture Bottle (Colorimetric Method) - Resin Anaerobic Bottle (AN) [20 Bottles/box 100 bottles/box]Class A
MDIR-0006502ZYBIO (PCT Asaay CLIA) [1x50T/Kit, 2x50T/Kit, 1x100T/Kit, 2x100T/Kit]Class C
MDIR-0006503ZYBIO (NT-proBNP Assay immunofluroscence) [25T/kit]Class C
MDIR-0006504ZYBIO (Troponin T/CK-MB/Myoglobin Assay immunofluroscence) [1x25T/Kit, 2x25T/Kit, 4x25T/Kit, 6x25T/Kit, 8x25T/Kit]Class C

Similar devices from other companies

Same device type listed by other holders, useful when comparing suppliers.

MDIR-0007907Zybio Nucleic acid detection kit (Magnetic Bead Method) [RNA/DNA Extraction Kit]Class BAyyan Moleculer Products

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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.