Home / Device Screening / Nextek Healthcare / MDIR-0006601
DRAP registered medical device · imported

cTnI

Class C (moderate to high risk) · MDIR-0006601 · Nextek Healthcare

✓ DRAP status Listed Valid until 7 Apr 2029
Screened against DRAP's published lists

DRAP REGISTERED MEDICAL DEVICE

cTnI (CLIA) 130256002M, 130656002M is registered with DRAP under number MDIR-0006601 as a Class C (moderate to high risk) medical device, imported. The listed holder is Nextek Healthcare. It is listed as valid until 7 Apr 2029.

Screening result

i
Imported device, registered with DRAP as Class C (moderate to high risk)
MDIR-0006601 · the class is taken from DRAP's list for this number
✓
Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
✓
Listed valid until 7 Apr 2029
✓
Holder has a DRAP import licence on file
ELI-00619
DevicecTnI (CLIA) 130256002M, 130656002M
ClassC
Listed holderNextek Healthcare
Holder addressPlot No. 24-C, Lane-9, Khayaban-e-Ghazi, D.H.A. Phase 6, Karachi
Manufacturing siteM/s Shenzhen New Industries Biomedical Engineering Co., Ltd No.23, Jinxiu East Road, Pingshan District, 518122 Shenzhen, P.R. China
Issued8 Apr 2024
Renewal date7 Apr 2029
LicenceELI-00619

Specifications

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Screened 7 Oct 2026, 06:05 (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.

MDIR-0006598AFP (CLIA) 130201033M, 130601033MClass C
MDIR-0006599CA 125 (CLIA) 130201031M, 130601031MClass C
MDIR-0006600CRP (CLIA) 130266002M, 130666002MClass C
MDIR-0006602Cyclosporine (CLIA) 130257001M, 130657001MClass C
MDIR-0006603D-Dimer (CLIA) 130256008M, 130656008MClass C
MDIR-0006604Insulin (CLIA) 130255002M, 130655002MClass C
MDIR-0006605NT-proBNP (CLIA) 130256004M, 130656004MClass C
MDIR-0006606PCT (CLIA) 130266001M, 130666001MClass C
MDIR-0006607Syphilis (CLIA) 130269003M, 130669003MClass C
MDIR-0006608Total PSA (CLIA) 130201004M, 130601004MClass C
MDIR-0006609Tacrolimus (CLIA) 130257003M, 130657003MClass C
MDIR-0006610f-PSA (CLIA) 1130201005M, 130601005MClass C

Similar devices from other companies

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

MDMR-000523* GLOW cTnI/Myo/CK-MB Fluorescence Immunochromatograp hy KitClass CLab Diagnostic Systems (SMC) Pvt Ltd
MDIR-0009339EDiagnosis High-Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Immunofluorescence Method)Class CSure Bio Diagnostics & Pharmaceuticals
MDIR-0009335V-CHEK Cardiac Troponin I (cTnI) Rapid Test Kit [5184C4X025, 5184C4X050]Class CSure Bio Diagnostics & Pharmaceuticals
MDIR-0006508ZYBIO (cTnI Assay immunofluroscence) [1T/Kit, 1x10T/Kit, 1x25T/Kit, 2x25T/Kit, 4x25T/Kit, 6x25T/Kit, 8x25T/Kit]Class CZybio Medical Pakistan (SMC-Private) Limited
MDIR-0006516ZYBIO (cTnI Assay CLIA) [1x50T/Kit, 2x50T/Kit, 1x100T/Kit, 2x100T/Kit]Class CZybio Medical Pakistan (SMC-Private) Limited
MDIR-0005758RightSign Cardiac Troponin I Rapid Test Cassette [CTNI-C41/CTNI-C41 S]Class DShams Scientific Traders
MDIR-0005470Lifotronic Cardiac Troponin (cTnI) Assay Kits (Lateral flow immunoassay)Class CMOODY Global Services

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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.