DRAP REGISTERED MEDICAL DEVICE
FCI Purified Silicone Oil [S5.7160 (15mL-1000CST in Syringe) S5.7170 (10mL-1000CST in Syringe) S5.7500 (15mL-5000CST in Vial) S5.7560 (15mL-5000CST in Syringe) S5.7570 (10mL-5000CST in Syringe] is registered with DRAP under number MDIR-0004314 as a Class C (moderate to high risk) medical device, imported. The listed holder is Ophthalmo -Tec. It is listed as valid until 19 Dec 2027.
Screening result
MDIR-0004314
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00310
| Device | FCI Purified Silicone Oil [S5.7160 (15mL-1000CST in Syringe) S5.7170 (10mL-1000CST in Syringe) S5.7500 (15mL-5000CST in Vial) S5.7560 (15mL-5000CST in Syringe) S5.7570 (10mL-5000CST in Syringe] |
|---|---|
| Class | C |
| Listed holder | Ophthalmo -Tec |
| Holder address | Haji Fazal Ellahi Building, opp. Women Collage Shahrah -E- Liaquat. Karachi |
| Manufacturing site | M/s FCI S.A.S. France Chirurgie Instrumentation 20-22 rue Louis Armand, 75015 Paris, France M/s France Chirurgie Instrumentation SAS (FCI SAS) 2 rue Carl Zeiss 25000 Besancon M/s FCI SUD Ltd Vel Industrial Complex, Royal Road Mapou Leclezio, Goodlands-Mauritius |
| Issued | 20 Dec 2022 |
| Renewal date | 19 Dec 2027 |
| Licence | ELI-00310 |
Specifications
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Screened 5 Oct 2026, 06:37 (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-0002007 | FSSB Surgical Sutures FSSB Stahldraht (Steel Wire) [Stainless Steel 3/4/5/6/7] | Class D |
| MDIR-0002805 | FSSB Surgical Sutures (FSSB Polypropylene Blue) | Class D |
| MDIR-0002806 | FSSB Surgical Sutures (FSSB Polyglycolic Acid (PGA)) | Class D |
| MDIR-0003189 | FSSB Polyester white Sutures [2/0 G017PE(3) 3/0 A021PEG 4/0 A015PEW 5/0 A003PEW 5/0 H011PP 6/0 E100PEG… | Class D |
| MDIR-0004313 | FCI-Octa vial Perflourocarbons (PFCL) [S5.8250 (5mL) S5.8270 (7mL)] | Class C |
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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.