DRAP REGISTERED MEDICAL DEVICE
Pancreatic amylase CC FS (Pancreatic amylase) is registered with DRAP under number MDIR-0008626 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-0008626
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00619
| Device | Pancreatic amylase CC FS (Pancreatic amylase) |
|---|---|
| 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 5 Oct 2026, 01:38 (Pakistan time). A screening aid, not an official DRAP verification.
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Other DRAP registrations and enlistments listed for the same company.
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Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0008298 | Alinity c Pancreatic Amylase Reagent Kit [01R0422] | Class C | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0008299 | Pancreatic Amylase (For Architect c Instrument) [6K22-30] | Class C | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0003960 | Alinity c Pancreatic Amylase Reagent Kit | Class B | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0003961 | Pancreatic Amylase | Class B | Abbott Laboratories(Pakistan) Ltd |
Corrections
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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.