DRAP REGISTERED MEDICAL DEVICE
Spectra Optia Exchange Set [10220] is registered with DRAP under number MDIR-0003805 as a Class B (low to moderate risk) medical device, imported. The listed holder is Sure Bio Diagnostics & Pharmaceuticals. It is listed as valid until 10 Oct 2027.
Screening result
MDIR-0003805
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00084
| Device | Spectra Optia Exchange Set [10220] |
|---|---|
| Class | B |
| Listed holder | Sure Bio Diagnostics & Pharmaceuticals |
| Holder address | EE -10 Defence View Phase II, Near Iqra University Shaheed-e-Millat Express Way, Karachi |
| Manufacturing site | M/s Terumo BCT Inc. 10811 West Collins Ave., Lakewood, Colorado, 80215, USA. M/s TFB Manufacturing SRL Calle 58, Zona France La Lima Planta de Terumo BCT-Calle Duan y Avenida Turrialba La Lima, Guadalupe, 30106 Cartago, Costa Rica. |
| Issued | 11 Oct 2022 |
| Renewal date | 10 Oct 2027 |
| Licence | ELI-00084 |
Specifications
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Screened 5 Oct 2026, 01:06 (Pakistan time). A screening aid, not an official DRAP verification.
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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.