DRAP REGISTERED MEDICAL DEVICE
HISCL HbeAg Assay Kit CU-839-537 (Along with) HISCL HbeAg Calibrator AN-056-324 is registered with DRAP under number MDIR-0004500 as a Class D (high risk) medical device, imported. The listed holder is S. Ejazuddin & Co. It is listed as valid until 9 Jan 2028.
Screening result
MDIR-0004500 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00078
| Device | HISCL HbeAg Assay Kit CU-839-537 (Along with) HISCL HbeAg Calibrator AN-056-324 |
|---|---|
| Class | D |
| Listed holder | S. Ejazuddin & Co |
| Holder address | Zia Plaza Altaf Hussain Road Karachi |
| Manufacturing site | M/s Japan Lyophilization Laboratory 1-5-21 Otsuka, Bunkyo-ku, Tokyo 112-0012,Japan M/s Japan Lyophilization Laboratory Kiyose Factory 3-1-5 Matsuyama, Kiyose-shi, Tokyo, 204-0022 Japan M/s Sysmex International Reagents Co., Ltd., one factory 17 takhumidai one-shihyogo 675-1322, Japan M/s Sysmex International Reagents Co., Ltd., seishin factory 4-3-2 takatsukadai, nishi-ku, kobe-shi, hyogo 651-2271 Japan |
| Issued | 10 Jan 2023 |
| Renewal date | 9 Jan 2028 |
| Licence | ELI-00078 |
Specifications
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Screened 5 Oct 2026, 12:49 (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 |
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| 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.