Nigale Plaelet Apheresis Set
Class C (moderate to high risk) · MDIR-0003760 · Life-Tec
DRAP REGISTERED MEDICAL DEVICE
Nigale Plaelet Apheresis Set (Disposable Blood Component Apheresis Set) [P-2000IS] is registered with DRAP under number MDIR-0003760 as a Class C (moderate to high risk) medical device, imported. The listed holder is Life-Tec. It is listed as valid until 12 Sep 2027.
Screening result
MDIR-0003760 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00155
| Device | Nigale Plaelet Apheresis Set (Disposable Blood Component Apheresis Set) [P-2000IS] |
|---|---|
| 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., No.28, Kuixing Road, Dongxi town, 641400, Jianyang, Sichuan, People's Republic of China |
| Issued | 13 Sep 2022 |
| Renewal date | 12 Sep 2027 |
| Licence | ELI-00155 |
Specifications
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Screened 7 Oct 2026, 07:51 (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.
| 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-0004530 | Nigale Platelet Apheresis Set / Kit (P-2000IE) with ACD (Acid Citrate Dextrose) (Disposable blood component apheresis… | Class D |
| MDIR-0004871 | Therapeutic Plasma Exchange (TPE) Machine with ACD (Acid Citrate Dextrose) solution | Class C |
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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.
