DRAP REGISTERED MEDICAL DEVICE
HbA1c Kit Audicom (HbA1c Kit) is registered with DRAP under number MDIR-0009089 as a Class B (low to moderate risk) medical device, imported. The listed holder is Bio Sphere Marketing. It is listed as valid until 15 Apr 2030.
Screening result
i
Imported device, registered with DRAP as Class B (low to moderate risk)
MDIR-0009089 · the class is taken from DRAP's list for this number
MDIR-0009089 · the class is taken from DRAP's list for this number
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Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
DRAP registered Class B/C/D list, 28 Aug 2025
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Listed valid until 15 Apr 2030
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Holder has a DRAP import licence on file
ELI-00922
ELI-00922
| Device | HbA1c Kit Audicom (HbA1c Kit) |
|---|---|
| Class | B |
| 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 Jiangsu Audicom Medical Technology Co., Ltd. 4F, No. 4 Building, High-tech Industrial Park, No. 36 Nanwei 4 Rd., Dingmao, Zhenjiang, Jiangsu, China |
| Issued | 16 Apr 2025 |
| Renewal date | 15 Apr 2030 |
| Licence | ELI-00922 |
Specifications
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Screened 6 Oct 2026, 20:58 (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-0000947 | Laffinite II HbA1c Analyzer Hemoglobin Analyzer HPLC Based | Class A |
| 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 |
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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.