DRAP REGISTERED MEDICAL DEVICE
HiResolution™ Bionic Ear System - HiRes™ Ultra CI HiFocus™ SlimJ Electrode is registered with DRAP under number MDIR-0007379 as a Class D (high risk) medical device, imported. The listed holder is Heartec. It is listed as valid until 28 Oct 2029.
Screening result
MDIR-0007379 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00375
| Device | HiResolution™ Bionic Ear System - HiRes™ Ultra CI HiFocus™ SlimJ Electrode |
|---|---|
| Class | D |
| Listed holder | Heartec |
| Holder address | 1st Floor, 734, Shadman 1, inside Alam Audiology Clinic, District Lahore |
| Manufacturing site | M/s Advanced Bionics LLC 28515 Westinghouse Pl, Valencia, CA 91355, United States |
| Issued | 29 Oct 2024 |
| Renewal date | 28 Oct 2029 |
| Licence | ELI-00375 |
Specifications
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Screened 6 Oct 2026, 01:27 (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-0001775 | Oticon Medical Neurelec (Cochlear Implant Neuro ZTI) [35643, 47374, 61462] | Class D |
| MDIR-0001776 | Oticon Medical Neurelec (Cochlear Implant Digisonic SP) | Class D |
| MDIR-0007380 | HiResolution™ Bionic Ear System - HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode | Class D |
| MDIR-0007381 | Naida CI Q30 Sound Processor with accessories | Class D |
| MDIR-0007382 | Naida CI Q90 Sound Processor with accessories | Class D |
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.