DRAP REGISTERED MEDICAL DEVICE
Amicus Apheresis Kit-Double Needle with Platelet Additive solution Connector [X6R2302] is registered with DRAP under number MDIR-0001746 as a Class C (moderate to high risk) medical device, imported. The listed holder is Fresenius Kabi Pakistan (Pvt) Ltd.. Its listed renewal date (23 Aug 2025) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0001746 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00266
| Device | Amicus Apheresis Kit-Double Needle with Platelet Additive solution Connector [X6R2302] |
|---|---|
| Class | C |
| Listed holder | Fresenius Kabi Pakistan (Pvt) Ltd. |
| Holder address | First Floor, Tanwir Ahmed MEdical Center (TAMC), MM Alam Road, 27-C/3, Gulberg III, Lahore |
| Manufacturing site | M/s. Fresenius Kabi AG 61346, Bad Homburg Germany M/s Fenwal International Inc Carretera Sanchez Km 18.5, Parque Industrial Itabo, Zona Franca Ind. De S.C.Haina, Dominican Republic |
| Issued | 24 Aug 2020 |
| Renewal date | 23 Aug 2025 |
| Licence | ELI-00266 |
Specifications
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Screened 6 Oct 2026, 14:07 (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.
| MDIR-0001210 | AmiCORE Apheresis Kit Single Needle [Disposable Apheresis Kit] P6R8880-AmiCORE Apheresis Kit | Class C |
| MDIR-0001211 | AmiCORE Apheresis Kit Single Needle with two platelet Containers [Disposable Apheresis Kit] P6R8882-AmiCORE Apheresis Kit. | Class C |
| MDIR-0001741 | Compoflex 2F 63 ml CPDA-1 - PDS-V T211150 | Class D |
| MDIR-0001742 | Compoflex 1F 63 ml CPDA-1 - PDS-V T111150 | Class D |
| MDIR-0001743 | Compoflex 3F 63 ml CPD/100ml SAG-M - PDS-V T331150 | Class D |
| MDIR-0001744 | Compoflex 4F 63 ml CPD/100ml SAG-M - PDS-V T431150 | Class D |
| MDIR-0001745 | Amicus Apheresis Kit-Single Needle with Platelet Additive solution Connector X6R2301 | Class C |
| MDIR-0001814 | Agilia VP IN Reference :Z019597 | Class C |
| MDIR-0001815 | Agilia VP MC WIFI IN Reference :Z019797 | Class C |
| MDIR-0001816 | Agilia VP MC IN Reference: Z019697 | Class C |
| MDIR-0001817 | Agilia SP MC WIFI IN Reference :Z018797 | Class C |
| MDIR-0001818 | Agilia SP MC IN Reference: Z018697 | Class C |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0007401 | Amicus TPE plasma exchange kit X7R2349 Apheresis Kits [X7R2349] | Class C | Uniplan Trade International Pvt ltd |
| MDIR-0007402 | Amicus MNC apheresis kit double needle X7R2326 Apheresis Kits [X7R2326] | Class C | Uniplan Trade International Pvt ltd |
| MDIR-0007403 | Amicus Apheresis Kitdouble needle with platelet addictive solution connector X7R2302 Apheresis Kits [X7R2302] | Class C | Uniplan Trade International Pvt 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.