DRAP REGISTERED MEDICAL DEVICE
Sysmex Automated Hematology Analyzer (XS-Series) Reagents & Control is registered with DRAP under number MDIR-0003430 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-0003430 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00078
| Device | Sysmex Automated Hematology Analyzer (XS-Series) Reagents & Control |
|---|---|
| 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, Hyogo, 651-0073, Japan M/s Sysmex Corporation Kakogawa Factory 314-2 Kitano, Naguchi-cho, Kakogawa, Hyogo 675-0011 Japan M/s Sysmex International Reagents Co., Ltd., Ono factory 17 Takumidai, Ono, Hyogo 675-1322, Japan M/s Sysmex Asia Pacific Pte Ltd., 19, Jalan Tukang Sambo Innovation Building 619265 Singapore M/s Streck, Inc., 7002 S.109th Street, La Vista, NE, 68128, United States |
| Issued | 13 Jun 2022 |
| Renewal date | 12 Jun 2027 |
| Licence | ELI-00078 |
Specifications
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Screened 6 Oct 2026, 14:51 (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
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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.