DRAP REGISTERED MEDICAL DEVICE
Sysmex (HISCL Alfa-fetoprotein(AFP) Assay Kit) [BE-982-752(AFP Assay Kit) CM-302-833 (AFP Calibrator)] is registered with DRAP under number MDIR-0005921 as a Class C (moderate to high risk) medical device, imported. The listed holder is S. Ejazuddin & Co. It is listed as valid until 17 Dec 2028.
Screening result
MDIR-0005921
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00078
| Device | Sysmex (HISCL Alfa-fetoprotein(AFP) Assay Kit) [BE-982-752(AFP Assay Kit) CM-302-833 (AFP Calibrator)] |
|---|---|
| Class | C |
| Listed holder | S. Ejazuddin & Co |
| Holder address | Zia Plaza Altaf Hussain Road Karachi |
| Manufacturing site | M/s Kainos Laboratories, Inc. 38-18, Hongo 2-Chome, Bunkyo-ku Tokyo 113-0033 Japan M/s Kainos Laboratories, Inc. Kasama Research institute & distribution center 3-5, Aza Yarokuuchi, Inada, Kasama, Ibaraki, 309-1635 Japan |
| Issued | 18 Dec 2023 |
| Renewal date | 17 Dec 2028 |
| Licence | ELI-00078 |
Specifications
No supplier specifications yet.
Supplier of this device? Add specifications (free during launch)
Sign in or create a free account to add specifications.
Screened 4 Oct 2026, 23:52 (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-0000131 | DG Gel Sol (2x100 ml) Ref No: 210354 | Class A |
| MDIE-0000354 | Sysmex Automated Hematology Analyzer XP series Model: XP-100 [Code: BS649542 (Analyzer) BD347455 (Card_assay No. 25)] | Class A |
| MDIE-0000355 | Sysmex Automated Hematology Analyzer XP series Model: XP-300 [Code: AK007119] | Class A |
| MDIE-0000562 | Sysmex Automated Blood Coagulation Analyzer [CA-660] | Class A |
| MDIE-0000774 | VACUETTE Blood Collection Tubes | Class A |
| MDIE-0000775 | SAMPLIX Blood Collection Tubes | Class A |
| MDIE-0001734 | Semi-automated Blood Coagulation Analyzer CA-104 | Class A |
| MDIE-0001735 | Semi-automated Blood Coagulation Analyzer CA-101 | Class A |
| MDIR-0000341 | JMS Blood Bag CPDA-1 (Q) 500+300ml x 3, 17G (Quadruple Bag) | Class D |
| MDIR-0000342 | JMS Blood Bag CPDA-1 (T) 500+300mlx2, 17G (Triple Bag) | Class D |
| MDIR-0000343 | JMS Blood Bag CPDA-1 (D) 500+300mlx2, 17G (Double Bag) | Class D |
| MDIR-0000344 | JMS Blood Bag CPDA-1 (S) 250ml, 17G (Single Bag) | Class D |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIE-0000400 | Sysmex Automated Hematology Analyzer XS Series (XS-500i) | Class A | S. Ejazuddin & Co |
| MDIE-0000401 | Sysmex Automated Hematology Analyzer XS Series(XS-800i) | Class A | S. Ejazuddin & Co |
| MDIE-0000402 | Sysmex Automated Hematology Analyzer XS Series(XS-1000i) | Class A | S. Ejazuddin & Co |
Corrections
Is something on this page wrong? Report a correction
Corrections are checked against the evidence before anything changes on this page.
Screen another number
Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.