DRAP REGISTERED MEDICAL DEVICE
Nigale Disposable Plasma Apheresis Set [P-4018] is registered with DRAP under number MDIR-0002090 as a Class C (moderate to high risk) medical device, imported. The listed holder is Life-Tec. Its listed renewal date (28 Jan 2026) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0002090 · 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-00155
| Device | Nigale Disposable Plasma Apheresis Set [P-4018] |
|---|---|
| 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/F,Unit 2, Bldg 1, No, 401 Sheng an street, Hi-Tech Dist. Chengdu, Sichuan, P.R, China. M/s Sichuan Nigale Biotechnology Co, Ltd. No.28, Kuixing Road, dongxi Town, &41400 Jianyang, Sichuan, China |
| Issued | 29 Jan 2021 |
| Renewal date | 28 Jan 2026 |
| Licence | ELI-00155 |
Specifications
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Screened 6 Oct 2026, 10:23 (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-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 |
| MDIR-0004871 | Therapeutic Plasma Exchange (TPE) Machine with ACD (Acid Citrate Dextrose) solution | Class C |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0007228 | NIGALE Plasma separator [DIGI PLA 80] | Class C | MOODY Global Services |
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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.