Hydra Aortic Valve [HYDRA 22, HYDRA 26, HYDRA 30] - DRAP MDIR-0009535 (Class D)

DRAP REGISTERED MEDICAL DEVICE

Hydra Aortic Valve [HYDRA 22, HYDRA 26, HYDRA 30] is registered with DRAP under number MDIR-0009535 as a Class D (high risk) medical device, imported. The listed holder is Global Biotech Medical Devices (Private) Limited. It is listed as valid until 26 May 2030.

Screening result

i
Imported device, registered with DRAP as Class D (high risk)
MDIR-0009535 · 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 26 May 2030
i
Holder not found in DRAP's published licence list
That list covers manually issued licences only. Ask for a copy of the establishment licence.
DeviceHydra Aortic Valve [HYDRA 22, HYDRA 26, HYDRA 30]
ClassD
Listed holderGlobal Biotech Medical Devices (Private) Limited
Holder addressFirst Floor of Plot No. 35-N/3, PECHS Block-6, Near Rohail Khund Society, Karachi
Manufacturing siteM/s Vascular Innovations Co. Ltd. 88/38 Moo 1, 345 Road, Bangtanai Sup-District, Pakkret District, Nonthaburi 11120, Thailand M/s Siam Steri Service Co. Ltd (SIS)700/644, Amata City Chonburi, Moo 3, Tambol Bankao, Amphur Pantong, Chonburi 20160, Thailand. [For Sterilization]
Issued27 May 2025
Renewal date26 May 2030

Specifications

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Screened 5 Oct 2026, 15:59 (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.

MDIE-0002137Medk Radial Compression BandageClass A
MDIE-0002138Medk Guide Wire TorquerClass A
MDIE-0002139Medk Guide Wire Insertion ToolClass A
MDIE-0002140Medk Indeflation Syringe Catheter/Over Tube Balloon inflator, Single UseClass A
MDIR-0009536Hydra Aortic Valve Delivery System [HYDRA 18F]Class D
MDIR-0009537Hydra Aortic Valve Loading System [HYDRA 18VLS]Class D

Corrections

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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.