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DRAP registered medical device · imported

Nigale Plaelet Apheresis Set

Class C (moderate to high risk) · MDIR-0003760 · Life-Tec

✓ DRAP status Listed Valid until 12 Sep 2027
Screened against DRAP's published lists

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

i
Imported device, registered with DRAP as Class C (moderate to high risk)
MDIR-0003760 · the class is taken from DRAP's list for this number
✓
Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
✓
Listed valid until 12 Sep 2027
✓
Holder has a DRAP import licence on file
ELI-00155
DeviceNigale Plaelet Apheresis Set (Disposable Blood Component Apheresis Set) [P-2000IS]
ClassC
Listed holderLife-Tec
Holder addressUnit B, 1st Floor, Block 20D, G-8 Markaz Islamabad.
Manufacturing siteM/s Sichuan Nigale Biotechnology Co, Ltd., No.28, Kuixing Road, Dongxi town, 641400, Jianyang, Sichuan, People's Republic of China
Issued13 Sep 2022
Renewal date12 Sep 2027
LicenceELI-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-0002090Nigale Disposable Plasma Apheresis Set [P-4018]Class C
MDIR-0002091Nigale Plasma Separator [Model: NGL XJC 2000]Class C
MDIR-0002092Nigale Disposable Blood Components Apheresis Set [Model: P-2000IA]Class C
MDIR-0002093Nigale Blood Component Separator [NGL XCF-3000]Class C
MDIR-0004530Nigale Platelet Apheresis Set / Kit (P-2000IE) with ACD (Acid Citrate Dextrose) (Disposable blood component apheresis…Class D
MDIR-0004871Therapeutic Plasma Exchange (TPE) Machine with ACD (Acid Citrate Dextrose) solutionClass C

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.