DRAP ENLISTED MEDICAL DEVICE
Laffinite II HbA1c Analyzer Hemoglobin Analyzer HPLC Based is enlisted with DRAP under number MDIE-0000947 as a Class A (low risk) medical device, imported. The listed holder is Bio Sphere Marketing. It is listed as valid until 13 Feb 2030.
Screening result
MDIE-0000947 · the class is taken from DRAP's list for this number
DRAP enlisted Class A list, 28 Aug 2025
ELI-00922
| Device | Laffinite II HbA1c Analyzer Hemoglobin Analyzer HPLC Based |
|---|---|
| Class | A |
| Listed holder | Bio Sphere Marketing |
| Holder address | H.No.02, St No. 04, Adjacent to the best grammar School, Park Town, Chungi Amar Sidhu, Lahore |
| Manufacturing site | M/s AE HEALTH LIMITED Floor 11, Building 1B, BTR Technology Park, Longtian Street, Pingshan District, Shenzhen, China |
| Issued | 14 Feb 2025 |
| Renewal date | 13 Feb 2030 |
| Licence | ELI-00922 |
Specifications
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Screened 6 Oct 2026, 22:36 (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-0000948 | AUDICOM AC6601 HbA1c Analyzer (HbA1c Analyzer Model AC6601) | Class A |
| MDIE-0001341 | EH8300 Hematology Analyzer (Automatic Hematology Analyzer) | Class A |
| MDIR-0008424 | Hemoglobin Test kit for Laffinite II (HbA1c Reagent kit) [500 Tests/kit] | Class B |
| MDIR-0009089 | HbA1c Kit Audicom (HbA1c Kit) | Class B |
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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.