D-Dimer - DRAP MDIR-0006603 (Class C)

DRAP REGISTERED MEDICAL DEVICE

D-Dimer (CLIA) 130256008M, 130656008M is registered with DRAP under number MDIR-0006603 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-0006603 · 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
DeviceD-Dimer (CLIA) 130256008M, 130656008M
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 6 Oct 2026, 06:06 (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-0006601cTnI (CLIA) 130256002M, 130656002MClass C
MDIR-0006602Cyclosporine (CLIA) 130257001M, 130657001MClass 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.

MDIE-0002156Helena Biosciences Europe D-Dimer Control [REF 5509]Class APrincess Scientific Services
MDMR-000522* GLOW D-Dimer Fluorescence Immunochromatograp hy KitClass CLab Diagnostic Systems (SMC) Pvt Ltd
MDIR-0009333V-CHEK D Dimer (DD) Rapid Test Kit [5274C4X025, 5274C4X050]Class CSure Bio Diagnostics & Pharmaceuticals
MDIR-0006507ZYBIO (D-Dimer Assay immunofluroscence) [1x25T/Kit, 2x25T/Kit, 4x25T/Kit, 6x25T/Kit 8x25T/Kit]Class CZybio Medical Pakistan (SMC-Private) Limited
MDIR-0006517ZYBIO (D-Dimer Assay CLIA) [1x50T/Kit, 2x50T/Kit, 1x100T/Kit, 2x100T/Kit]Class CZybio Medical Pakistan (SMC-Private) Limited
MDIR-0006526ZYBIO (D-Dimer kit latex enhanced Immunoturbidimetric method) [6x48T/Kit, 6x64T/Kit,Class CZybio Medical Pakistan (SMC-Private) Limited
MDIR-0005716D-Dimer 01R1022 D-Dimer Calibrator 01R1001 D-Dimer Controls 01R1010Class CAbbott Laboratories(Pakistan) Ltd
MDIR-0005691BE D-DIMER (Reagent for Turbidimetric Immunoassay) [771500]Class CHasnain Scientific
MDIR-0005472Lifotronic D-dimer Assay Kits (Lateral flow immunoassay)Class CMOODY Global Services
MDIR-0005193Helena Biosciences (Auto Red D-Dimer 700) {Model: 5501}Class CPrincess Scientific 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.