DRAP REGISTERED MEDICAL DEVICE
External Single Chamber Pacemaker PACE 101 is registered with DRAP under number MDIR-0001212 as a Class C (moderate to high risk) medical device, imported. The listed holder is Claris Medical. Its listed renewal date (20 Jan 2025) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0001212 · 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-00269
| Device | External Single Chamber Pacemaker PACE 101 |
|---|---|
| Class | C |
| Listed holder | Claris Medical |
| Holder address | Flat/Unit No.27, 3rd Floor, Twin City Plaza, I-8 Markaz, Islamabad, Godown Address: Same as Above |
| Manufacturing site | M/s. Osypka Medical Albert-Einstein-Strasse 3, 12489, Berlin, Germany |
| Issued | 21 Jan 2020 |
| Renewal date | 20 Jan 2025 |
| Licence | ELI-00269 |
Specifications
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Screened 5 Oct 2026, 16:12 (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-0001213 | External Dual Chamber Pacemaker PACE 203 | Class C |
| MDIR-0002362 | MPS Delivery Set (Cardioplegia Delivery Set) [5001102, 5001102AS, 5161102] | Class D |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0007610 | Reocor Dual Chamber External Pacemaker [Reocor D 365529, 371263, 103704, 391843, 378007, 379384] | Class D | Flowtronix Systems |
| MDIR-0007621 | Reocor Single Chamber (External Pacemaker) [371263, 103704, 391843, 378007 379384, 365528] | Class D | Flowtronix Systems |
| MDIR-0002253 | Single Chamber Temporary External Pacemaker [Model: 53401] | Class C | Medtronic Pakistan (Pvt) Ltd. |
| MDIR-0000782 | Pace 101H (External Single Chamber Pacemaker) Model: 101H | Class C | Alliance Medical |
| MDIR-0000783 | Pace 203H (External Dual Chamber Pacemaker) Model: 203H | Class C | Alliance Medical |
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.