DRAP REGISTERED MEDICAL DEVICE
Therapeutic Plasma Exchange (TPE) Machine with ACD (Acid Citrate Dextrose) solution is registered with DRAP under number MDIR-0004871 as a Class C (moderate to high risk) medical device, imported. The listed holder is Life-Tec. It is listed as valid until 26 Feb 2028.
Screening result
MDIR-0004871
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00155
| Device | Therapeutic Plasma Exchange (TPE) Machine with ACD (Acid Citrate Dextrose) solution |
|---|---|
| Class | C |
| Listed holder | Life-Tec |
| Holder address | Unit B, 1st Floor, Block 20D, G-8 Markaz Islamabad. |
| Manufacturing site | M/s Sichuan Nigale Biotechnology Co., Ltd., Office # 901-910, 9/FUnit 2, Bldg 1, No. 401 Shengan street, Hi-tech District, Chnegdu, Sichuan, China. M/s Sichuan Nigale Biotechnology Co., Ltd No. 28 Kuixing road, 641400 Jianyang, Sichuan China |
| Issued | 27 Feb 2023 |
| Renewal date | 26 Feb 2028 |
| Licence | ELI-00155 |
Specifications
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Screened 5 Oct 2026, 12:28 (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-0002090 | Nigale Disposable Plasma Apheresis Set [P-4018] | Class C |
| MDIR-0002091 | Nigale Plasma Separator [Model: NGL XJC 2000] | Class C |
| MDIR-0002092 | Nigale Disposable Blood Components Apheresis Set [Model: P-2000IA] | Class C |
| MDIR-0002093 | Nigale Blood Component Separator [NGL XCF-3000] | Class C |
| MDIR-0003760 | Nigale Plaelet Apheresis Set (Disposable Blood Component Apheresis Set) [P-2000IS] | Class C |
| MDIR-0004530 | Nigale Platelet Apheresis Set / Kit (P-2000IE) with ACD (Acid Citrate Dextrose) (Disposable blood component apheresis… | 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.