DRAP REGISTERED MEDICAL DEVICE
Reagents and controls for Sysmex Automated Hematology Analyzer XP series is registered with DRAP under number MDIR-0003426 as a Class B (low to moderate risk) medical device, imported. The listed holder is S. Ejazuddin & Co. It is listed as valid until 12 Jun 2027.
Screening result
MDIR-0003426 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00078
| Device | Reagents and controls for Sysmex Automated Hematology Analyzer XP series |
|---|---|
| Class | B |
| Listed holder | S. Ejazuddin & Co |
| Holder address | Zia Plaza Altaf Hussain Road Karachi |
| Manufacturing site | M/s SYSMEX CORPORATION 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan M/s SYSMEX COORPORATION Kakogawa Factory, 314-2 Kitano, Noguchi-cho, Kakogawa, Hyogo, 675-0011, Japan M/s Sysmex Asia Pacific Pte. Ltd 19 Jalan Tukang, Sambo Innovation Building 619265, Singapore M/s Streck, Inc. 7002 South 109th St LA Vista NE 68128, USA M/s Sysmex Internation Reagents Co., Ltd., Ono Factory 17 Takumidai, Ono, Hyogo 675-1322, Japan |
| Issued | 13 Jun 2022 |
| Renewal date | 12 Jun 2027 |
| Licence | ELI-00078 |
Specifications
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Screened 6 Oct 2026, 06:01 (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 |
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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.