Urea FS
Class B (low to moderate risk) · MDIR-0008620 · Nextek Healthcare
DRAP REGISTERED MEDICAL DEVICE
Urea FS (Urea) is registered with DRAP under number MDIR-0008620 as a Class B (low to moderate risk) medical device, imported. The listed holder is Nextek Healthcare. It is listed as valid until 27 Mar 2030.
Screening result
MDIR-0008620 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00619
| Device | Urea FS (Urea) |
|---|---|
| Class | B |
| Listed holder | Nextek Healthcare |
| Holder address | Plot No. 24-C, Lane-9, Khayaban-e-Ghazi, D.H.A. Phase 6, Karachi. |
| Manufacturing site | M/s DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany |
| Issued | 28 Mar 2025 |
| Renewal date | 27 Mar 2030 |
| Licence | ELI-00619 |
Specifications
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Screened 7 Oct 2026, 04:53 (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.
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| MDIR-0006603 | D-Dimer (CLIA) 130256008M, 130656008M | Class C |
| MDIR-0006604 | Insulin (CLIA) 130255002M, 130655002M | Class C |
| MDIR-0006605 | NT-proBNP (CLIA) 130256004M, 130656004M | Class C |
| MDIR-0006606 | PCT (CLIA) 130266001M, 130666001M | Class C |
| MDIR-0006607 | Syphilis (CLIA) 130269003M, 130669003M | Class C |
| MDIR-0006608 | Total PSA (CLIA) 130201004M, 130601004M | Class C |
| MDIR-0006609 | Tacrolimus (CLIA) 130257003M, 130657003M | Class C |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0009917 | BioMed Urea [2x60ml, 2x120ml, 2x50ml] | Class B | Mian Scientific Corporation (Pvt) Ltd. |
| MDIR-0009037 | BIOSYSTEMS Urea/BUN | Class B | Diag. M (Pvt) Limited |
| MDIR-0009038 | BIOSYSTEMS Urea/BUN | Class B | Diag. M (Pvt) Limited |
| MDIR-0004472 | LAUREATE ANTERIOR VIRECTOMY TIP [Virectomy System Handpiece Tip] [Codes: 180.01] | Class B | Medzntech (Pvt) Ltd |
| MDIR-0004343 | LAUREATE WORLD PHACO SYSTEM Cataract Lens Extraction Surgical Instrument [8065750502] | Class C | Medzntech (Pvt) Ltd |
| MDIR-0003997 | Cholesterol2 [04S9220 ,04S9230] Creatinine2 [04S9520] Urea Nitrogen2 [04T1220, 04T1230] Uric Acid2 [04T1320, 04T1330 | Class B | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0004003 | Urea Nitrogen2 [04U0820, 04U0830] | Class B | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0002955 | PolyPlus UBT Kit 13C Urea Breath Test [PPUBTK] | Class B | Future Scientific |
| MDIR-0002600 | Alinity c Glucose, Creatinine, Urea Nitrogen, Uric Acid, Multiconstituent Calibrator | Class B | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0001903 | Glucose, Creatinine, Urea Nitrogen, Uric Acid, Multiconstituent Calibrator | Class B | Abbott Laboratories(Pakistan) Ltd |
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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.