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Sr. No. Name & Address of Establishment Manufacturer Details Medical Device Name R & I Details Date (R&I) 1 Safe

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Sr. No. Name & Address of Establishment Manufacturer Details Medical Device Name R & I Details Date (R&I) 1 Safe "Following is the provisional list of applications received for registration of products on FORM-7A with the Division of Medical Devices & Medicated Cosmetics, Drug Regulatory Authority of Pakistan, Islamabad under provision of SRO 32(I)/2018 dated 16-01-2018. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of date mentioned against each application. Disclaimer: The contents of this list shall not be used as reference for any purpose including litigation, claim, right, research, citation, statistical analysis, etc and are for information only. Errors and omissions are accepted and at provisional stage the DRAP shall not be responsible for any legal claim and liability" APPLICATION FOR THE GRANT OF REGISTRATION OF MEDICAL DEVICE (FORM 7-A IMPORTER) SINDH/ BALOCHISTAN Name & Address of Sr. No. Manufacturer Details Medical Device Name R & I Details Date (R&I) Establishment Safe Health Pakistan Bizcon, Legal Manufacturer: Disposable Infusion set with 20149 09/10/2019 Office No.25, 2nd Floor, M/s Guamgdong intmed Medical Needle:A1-B1 Type & A1-B3 Dilkusha Chamber, Marston Appliance Co., Ltd., 1 No. South Type Road, Karachi Shunhe Road Europe Industry 1 (ELI-00275) Park, Shunde, District, Foshan Codes & Sizes as per FSC City, Guangdong, China FSC China Valid Till (30-06-2019) Muller & Phipps Pakistan (Pvt) Legal Manufacturer: Contour Plus One 20146 09/10/2019 Ltd., Uzma Court, Main M/s Ascensia Diabetes Care Clifton Road, Karachi Holdings AG Peter Merian-Strasse Codes & Sizes as per FSC (ELI-00030) 90 4052 Basel, Switzerland 2 FSC Switzerland Valid Till (23-07-2022) Safe Health Pakistan Bizcon, Legal Manufacturer: Disposable Syringes with 20936-B 16/10/2019 Office No.25, 2nd Floor, M/s Guangdong Intmed Medical Needle Dilkusha Chamber, Marston Appliance Co., Ltd., South Shunhe (30ml & 50ml) Road, Karachi Road Europe Industry Park, (ELI-00275) Shunde, District, Foshan City, Codes & Sizes as per FSC 3 Guangdong, China FSC China Valid Till (30-06-2019) FSC Ireland Valid Till (23-07-2019) Safe Health Pakistan Bizcon, Legal Manufacturer: Bao Helath 20935 16/10/2019 Office No.25, 2nd Floor, M/s Bao Health Medical (Ostomy Care) Dilkusha Chamber, Marston Instrument Co., Ltd., 2nd Floor of Road, Karachi 8-2 Building, Gaoqiao Industrial Codes & Sizes as per FSC 4 (ELI-00275) Zone, Tongxiang, Zhejiang, P.R. China FSC China Valid Till (19-07-2020) Safe Health Pakistan Bizcon, Legal Manufacturer: Disposable Syringes with 20936-A 16/10/2019 Office No.25, 2nd Floor, M/s Guangdong Intmed Medical Needle Dilkusha Chamber, Marston Appliance Co., Ltd., South Shunhe (1ml, 2ml, 2.5ml, 3ml, 5ml, Road, Karachi Road Europe Industry Park, 10ml, 20ml) (ELI-00275) Shunde, District, Foshan City, 5 Guangdong, China Codes & Sizes as per FSC FSC China Valid Till (30-06-2019) FSC Ireland Valid Till (23-07-2019) Zenith International, Room Legal Manufacturer: Jasun Digital 21208 18/10/2019 No.104, Tahir Plaza, A/20, M/s Hangzhou Huaan Medical & Sphygmomanometer Block 7 & 8 KCHSU, Karachi Health Instruments Co., Ltd. (ELI-00090) Building 2, 1 No. Fuzhu Nan Codes & Sizes as per FSC Road, Wuchang Town, Yuhang 6 District, Hangzhou Zhejiang, China FSC China Valid Till (29-07-2021) Johnson & Johnson Pakistan Legal Manufacturer: Harmonic Hand Piece 21546 22/10/2019 (Pvt) Ltd., Office No.806, 8th M/s Ethicon Endo-Surgery, LLC, Floor, Horizon Tower, Block 3, 475 Calle C Guaynabo, Puerto Codes & Sizes as per FSC Scheme 5, Clifton, Karachi Rico, 00969 USA (ELI-00154) Manufacturing Site: M/s Ethicon Endo-Surgery S.A. 7 DE C.V. Planta II, Calle Durango 2751, Colonia Lote Bravo, Ciudad Juarez, Chihuahua, 32575, Mexico FSC USFDA Valid Till (30-10-2020) Melamine Emporium, Office Legal Manufacturer: Tianck Sterile Introducer Set 21917 24/10/2019 No.814, Star City Mall, M/s Tianck Medical Co., Ltd., Saddar, Karachi Building C, No.16 Yinkui Road, Codes & Sizes as per FSC (ELI-00414) Kuichong Town, Dapeng New 8 District, Shenzhen 518119, China FSC UK Issuance (26-03-2018) Melamine Emporium, Office Legal Manufacturer: Tianck Hemostasis Valve Set 21917 24/10/2019 No.814, Star City Mall, M/s Tianck Medical Co., Ltd., Saddar, Karachi Building C, No.16 Yinkui Road, Codes & Sizes as per FSC (ELI-00414) Kuichong Town, Dapeng New 9 District, Shenzhen 518119, China FSC UK Issuance (26-03-2018) Melamine Emporium, Office Legal Manufacturer: Tianck Disposable Manifold 21917 24/10/2019 No.814, Star City Mall, M/s Tianck Medical Co., Ltd., Saddar, Karachi Building C, No.16 Yinkui Road, Codes & Sizes as per FSC (ELI-00414) Kuichong Town, Dapeng New 10 District, Shenzhen 518119, China FSC UK Issuance (26-03-2018) Melamine Emporium, Office Legal Manufacturer: Tianck Guidewire 21917 24/10/2019 No.814, Star City Mall, M/s Tianck Medical Co., Ltd., Saddar, Karachi Building C, No.16 Yinkui Road, Codes & Sizes as per FSC (ELI-00414) Kuichong Town, Dapeng New 11 District, Shenzhen 518119, China FSC UK Issuance (26-03-2018) Melamine Emporium, Office Legal Manufacturer: Tianck Balloon Inflation 21917 24/10/2019 No.814, Star City Mall, M/s Tianck Medical Co., Ltd., Device Kit Saddar, Karachi Building C, No.16 Yinkui Road, (ELI-00414) Kuichong Town, Dapeng New Codes & Sizes as per FSC 12 District, Shenzhen 518119, China FSC UK Issuance (26-03-2018) Melamine Emporium, Office Legal Manufacturer: Tianck Closure Pad 21917 24/10/2019 No.814, Star City Mall, M/s Tianck Medical Co., Ltd., Saddar, Karachi Building C, No.16 Yinkui Road, Codes & Sizes as per FSC (ELI-00414) Kuichong Town, Dapeng New 13 District, Shenzhen 518119, China FSC UK Issuance (26-03-2018) Abbott Laboratories (Pakistan) Legal Manufacturer: Alinity c Lp(a) Reagent Kit 2204 28/10/2019 Ltd. Opp. Radio Pakistan M/s BIOKIT, S.A. Can Male S/N Alinity c Lp (a) Calibrators Transmission Centre, 08186 LLICA D Amunt Alinity c Lp (a) Controls Kit 14 Hyderabad Road, Landhi, (Barcelona) Spain. Karachi Codes & Sizes as per FSC (ELI-00019) FSC Spain Issuance Date (24-01-2019) Abbott Laboratories (Pakistan) Legal Manufacturer: Alinity c Myoglobin Reagent 2204 28/10/2019 Ltd. Opp. Radio Pakistan M/s BIOKIT, S.A. Can Male S/N Kit Transmission Centre, 08186 LLICA D Amunt Hyderabad Road, Landhi, (Barcelona) Spain. Alinity c Myoglobin Standard Karachi 15 (ELI-00019) FSC Spain Issuance Date Alinity c Ferritin/Myoglobin (24-01-2019) /IgE Control Kit Codes & Sizes as per FSC Abbott Laboratories (Pakistan) Legal Manufacturer: Alinity c A1-AGP Reagent Kit 22049 28/10/2019 Ltd. Opp. Radio Pakistan M/s BIOKIT, S.A. Can Male S/N Transmission Centre, 08186 LLICA D Amunt Alinity c A1-Antitryspin Hyderabad Road, Landhi, (Barcelona) Spain. Reagent Kit Karachi (ELI-00019) FSC Spain Issuance Date Alinity C B2-Microglobulin (24-01-2019) Reagent Kit 16 Alinity c B2 Microglobulin Standard Alinity c Proteins Standard Codes & Sizes as per FSC Abbott Laboratories (Pakistan) Legal Manufacturer: Cystatin C 2204 28/10/2019 Ltd. Opp. Radio Pakistan M/s Sentinel CH. Spa Via Robert Cystatin C Calibrator Transmission Centre, Koch 2-20152 Milano, Italy. Cystatin C Control Set Hyderabad Road, Landhi, Fructosamine 17 Karachi FSC Italy Issuance Date Fructosamine Control 1 (ELI-00019) (18-10-2018) Fructosamine Control 2 Codes & Sizes as per FSC Abbott Laboratories (Pakistan) Legal Manufacturer: HBDH 2204 28/10/2019 Ltd. Opp. Radio Pakistan M/s Sentinel CH. Spa Via Robert Clin Chem Cal Transmission Centre, Koch 2-20152 Milano, Italy. Clin Chem Control 1 18 Hyderabad Road, Landhi, Clin Chem Control 2 Karachi FSC Italy Issuance Date (ELI-00019) (18-10-2018) Codes & Sizes as per FSC Abbott Laboratories (Pakistan) Legal Manufacturer: Architect 2nd Generation 2204 28/10/2019 Ltd. Opp. Radio Pakistan M/s Abbott GmbH & Co KG Max- Testosterone Transmission Centre, Planck-Ring 2 65205 Wiesbaden, Architect SHBG 19 Hyderabad Road, Landhi, Germany. Architect DHEA-S Karachi (ELI-00019) FSC Germany Issuance Date Codes & Sizes as per FSC (19-07-2018) Abbott Laboratories (Pakistan) Legal Manufacturer: Architect Intact PTH Reagent 2204 28/10/2019 Ltd. Opp. Radio Pakistan M/s Abbott GmbH & Co KG Max- Kit Transmission Centre, Planck-Ring 2 65205 Wiesbaden, Architect Intact PTH Hyderabad Road, Landhi, Germany. Calibrator 20 Karachi Architect Intact PTH Controls (ELI-00019) FSC Germany Issuance Date (19-07-2018) Codes & Sizes as per FSC Abbott Laboratories (Pakistan) Legal Manufacturer: Architect C-Peptide 2204 28/10/2019 Ltd. Opp. Radio Pakistan M/s Abbott GmbH & Co KG Max- Architect Insulin Transmission Centre, Planck-Ring 2 65205 Wiesbaden, Architect HbA1c 21 Hyderabad Road, Landhi, Germany. Karachi Codes & Sizes as per FSC (ELI-00019) FSC Germany Issuance Date (16-09-2019) Abbott Laboratories (Pakistan) Legal Manufacturer: Ammonia Ultra 2204 28/10/2019 Ltd. Opp. Radio Pakistan M/s Sentinel CH. Spa Via Robert Ammonia Controls Transmission Centre, Koch 2-20152 Milano, Italy. 22 Hyderabad Road, Landhi, Codes & Sizes as per FSC Karachi FSC Italy Issuance Date (ELI-00019) (18-06-2018) Abbott Laboratories (Pakistan) Legal Manufacturer: Quantia RF 2204 28/10/2019 Ltd. Opp. Radio Pakistan M/s BIOKIT, S.A. Can Male S/N Quantia RF Standard Transmission Centre, 08186 LLICA D Amunt Quantia ASO Hyderabad Road, Landhi, (Barcelona) Spain. Quantia ASO Standard 23 Karachi Quantia ASO-RF Control I (ELI-00019) FSC Spain Issuance Date Quantia ASO-RF Control II (24-01-2019) Codes & Sizes as per FSC Abbott Laboratories (Pakistan) Legal Manufacturer: Quantia IgE 2204 28/10/2019 Ltd. Opp. Radio Pakistan M/s BIOKIT, S.A. Can Male S/N Quantia IgE Standard Transmission Centre, 08186 LLICA D Amunt Quantia Hyderabad Road, Landhi, (Barcelona) Spain. Ferritin/Myoglobin/IgE Control 24 Karachi 2 (ELI-00019) FSC Spain Issuance Date (24-01-2019) Codes & Sizes as per FSC Abbott Laboratories (Pakistan) Legal Manufacturer: Dibucaine (CHE) 2204 28/10/2019 Ltd.
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