DRAP registered medical device · imported

HugeMed Flexible Video Ureterorenoscope System

Class B (low to moderate risk) · MDIR-0008875 · Ontech Corporation

✓ DRAP status Listed Valid until 7 Apr 2030
Screened against DRAP's published lists

DRAP REGISTERED MEDICAL DEVICE

HugeMed Flexible Video Ureterorenoscope System is registered with DRAP under number MDIR-0008875 as a Class B (low to moderate risk) medical device, imported. The listed holder is Ontech Corporation. It is listed as valid until 7 Apr 2030.

Screening result

i
Imported device, registered with DRAP as Class B (low to moderate risk)
MDIR-0008875 · 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 7 Apr 2030
✓
Holder has a DRAP import licence on file
ELI-00289
DeviceHugeMed Flexible Video Ureterorenoscope System
ClassB
Listed holderOntech Corporation
Holder addressB-154 Block 13-D/2, Gulshan-e-Iqbal, Karachi
Manufacturing siteM/s Shenzhen HugeMed Medical Technical Development Co., Ltd 416-1,516-1, Building 2, No. 1, Mawu Road, Baoan Community, Yuanshan Street, Longgang District, Shenzhen 518115, China
Issued8 Apr 2025
Renewal date7 Apr 2030
LicenceELI-00289

Specifications

No supplier specifications yet.

Supplier of this device? Add specifications (free during launch)

Sign in or create a free account to add specifications.

Screened 7 Oct 2026, 08:08 (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-0006582VERSIUS SURGICAL SYSTEM AND ACCESSORIESClass C
MDIR-0009047Plasti-Med Nephrostomy Catheter [Nephrostomy Catheter Locking Pigtail]Class B
MDIR-0009048Plasti-Med Nitinol Tipless Stone Basket [Nitinol Tipless Stone Basket]Class B
MDIR-0009049Plasti-Med Amplatz Renal Sheaths [Amplatz Renal Sheath]Class B
MDIR-0009050Plasti-Med Dilator [Fascial Dilator]Class B
MDIR-0009051Plasti-Med Ureteral CatheterClass B
MDIR-0009052Plasti-Med Suprapubic Catheter Set P/U [Suprapubic Catheter Set]Class B
MDIR-0009053Plasti-Med Needles [Initial Puncture Needle]Class B

Corrections

Is something on this page wrong? Report a correction

Corrections are checked against the evidence before anything changes on this page.

Screen another number

Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.