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الشركة المستوردة الشركة المصنعة اسم الجهاز رقم النموذج رقم شهادة المطابقة
Certification Nb
تصنيف الجهاز
مستوى الخطر
Classification
Providers ArthroCare Corporation Metallic Anchor 22-9055N CFG Nb: 5190-9-2011 II b
Providers ArthroCare Corporation Absorbable Anchors (Double Play) 22-6050N- 22-6065N CFG Nb: 5174-9-2011 III
Providers Osteon Anterior Cervical Cage (Impt) Refer to document attached CE-100534 QS/NB III
Providers ArthroCare Corporation Magnum Wire Suture OM-9054 CFG Nb: 5190-9-2011 II b
Saramed SAL Laboratoires Coloplast Kolibri set with J catheter RJA208 FQA DGM-410 II b
Saramed SAL Laboratoires Coloplast Double loop ureteral stents ACB152- ACB185 FQA DGM-410 II b
Saramed SAL Laboratoires Coloplast Double loop ureteral stents AJ4265- AJ4275 FQA DGM-410 II b
Saramed SAL Laboratoires Coloplast Novasilk mesh for surgical prolapse repair MS1515 0459 n.b./ FQA DGM-410 II b
Saramed SAL Laboratoires Coloplast Kolibri set with Malecot catheter RMA214 0543 n.b./ FQA DGM-410 II b
Saramed SAL Laboratoires Coloplast Single loop ureteral stents AC4407 0543 n.b./ FQA DGM-410 II b
Saramed SAL FB Medical IN-PORT VPP1026KT[S] FQA FR00151371.00 II b
Saramed SAL Laboratoires Coloplast Testicular Prostheses PR3002-PR3003 FQA DGM-410 II b
Dima Health Care Kasios SAS Duowedge K43504W; K43505W; K43506W; K43507W; K43508W; K43509W; K43510W; K43511W; K43512W; K43513W; K43514W; K43515W; K43516W; K43517W; K43518W; K43519W; K43520W CE-9460 rev-2 III
Dima Health Care Kasios SAS Jectos + J+441Z20 CE-8431 III
Dima Health Care Kasios SAS Kasios TCP K43105G-E; K43110G-E; K43115G-E; K43120G-E; K43105S-E; K43115B-E; K43120B-E; K43125B-E; K43108C-E; K43110C-E; K43112C-E; K43114C-E; K43106W-E; K43108W-E; K43110W-E; K43112W-E; K43114W-E CE-9691 III
Dima Health Care Kasios SAS KAGE RSF RSF 14-03; RSF 14-04; RSF 14-05; RSF 14-06; RSF 14-07; RSF 14-08; RSF 14-09; RSF 14-10; RSF 17-03; RSF 17-04; RSF 17-05; RSF 17-06; RSF 17-07; RSF 17-08; RSF 17-09; RSF 17-10 CE-16295 III
Dima Health Care Kasios SAS Jectos J406C05, J406C10 CE-8431 III
Dima Health Care Kasios SAS InBone TCP K4662303G; K4662305G; K4662310G; K466215G; K4662320G; K4664703G; K4664705G; K4664710G; K4664715G; K4664720G; K4664730G; K466005G; K466010G; K466020G; K466030G; K466105G; K466110G CE-14625 III
Dima Health Care Stryker Neurovascular Matrix Detachable Coils Refer to document attached DEKRA CE-38059870E01 III
Dima Health Care PAN MEDICAL LTD InterV kyphoplasty Kits… INTV-TDKC; INTV-TSKC; INTV-DDKC & INTV-TSKC   III
Dima Health Care Covidien Surgipro Mesh SMHP-01; SMHP-02; SMPL-01; SMPM-02; SPM-14; SPM-149; SPM-149W; SPM-14-W; SPM-35; SPM-35-W; SPM-66-W; SPMM-14; SPMM-149; SPMM-35; SPMM-46; SPMM-66 FDA- CFG- 21814-4-2013 II b
Dima Health Care Silimed-Industria de Implantes LTDA Gluteal Implants - Silicone Gel - Smooth Surface 10910-XXX; 13960-XXX; 13961-XXX (Note:… Ref: IUP 006-01-LP-EC) TUV Rheinland CE-HD600380820001 II b
Dima Health Care Silimed-Industria de Implantes LTDA Mammary Implants with Polyurethane surface 30535-XXX; 30535-XXXLO; 30535-XXXMD; 30535-XXXHI; 30535-XXXXH; 30615-XXX; 30621-XXX; 30622-XXXLO; 30622-XXXMD; 30622-XXXHI; 30622-XXXXH; 30626-XXX; 30635-XXXL; 30636-XXXL; 30637-XXXLO; 30637-XXXMD; 30637-XXXHI; 30637-XXXXH; 30644-XXXL; 30645-XXXL; 30646-XXXLO; 30646-XXXMD; 30646-XXXHI; 30646-XXXXH; 30646-XXXL;30674XXXLO; 30674-XXXMD; 30674-XXXHI; 30674-XXXXH; 30676-XXXL TUV Rheinland ID-600380850001 II b
Dima Health Care Silimed-Industria de Implantes LTDA Mammary Implants smooth surface 10512-XXX; 10521-XXX; 10521-XXXEA TUV Rheinland ID-600380850001 II b
Dima Health Care Silimed-Industria de Implantes LTDA Mammary Implants Textured surface 20621-XXX; 20621-XXXEA; 20622-XXXLO; 20622-XXXMD; 20622-XXXHI; 20622-XXXXH; 20630-XXX; 20630-XXXEAL; 20637-XXXLO; 20637-XXXMD; 20637-XXXHI; 20637-XXXXH; 20644-XXXL; 20645-XXXL; 20646-XXXL; 20646-XXXLO; 20646-XXXMD; 20646-XXXHI; 20646-XXXXH; 20674-XXXLO; 20674-XXXMD; 20674-XXXHI; 20674-XXXXH; 20676-XXXL TUV Rheinland ID-600380850001 II b
Dima Health Care Silimed-Industria de Implantes LTDA Nostril Retainer 1171-XXX (Note:…. Ref: IUP 029-02-L-EC R01) HD 600380820001 Tuv II a
Dima Health Care Silimed-Industria de Implantes LTDA Pectoral Implants - Silicone Gel - Smooth and Textured Surface 10130-XXX D/E; 20130-XXX D/E HD 600380820001 Tuv II b
Dima Health Care Silimed-Industria de Implantes LTDA Tissue Expanders 20730-XXX-1; 20760-XXX-1; 800-XXX-3; 20800-XXX-3; 807-XXX-1; 20807-XXX-1; 810-XXX-3; 20810-XXX-3; 817-XXX-1; 20817-XXX-1; 820-XXX-3; 20820-XXX-3; 827-XXX-1; 20827-XXX-1; 830-XXX-3; 20830-XXX-3; 841-016-1; 20841-016-1; 841-XXX-1; 20841-XXX-1; 851-XXX-1; 861-XXX-1; 880-XXX-1;881-XXX-1; 20787-XXX; 741-XXX-2; 808-XXX; 20739-XXX; 20769-XXX; 20769-XXXG; 20789-XXX; 20789-XXXG; 20759-XXX; 20759-XXXG; 20799-XXXA; 20799-XXXAG; 809-XXX; 20809-XXX; 20809-XXXG; 819-XXX; 20819-XXX; 829-XXX; 20829-XXX; 20829-XXXG; 206749-XXX; 206749G-XXX HD 600380820001 / FDA K981852 II b
Dima Health Care Boston Scientific Corporation Promus Premier Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System Refer to document attached 3807055CE01 III
Dima Health Care Boston Scientific Corporation Promus Element Monorail Everolimus-Eluting Coronary Stent System Refer to document attached 3807055CE01 III
Dima Health Care Boston Scientific Corporation Promus Element Plus Monorail Everolimus-Eluting Coronary Stent System Refer to document attached 3807055CE01 III
Dima Health Care Boston Scientific Corporation Promus Element Plus Monorail BTK Everolimus-Eluting Stent System Refer to document attached 3807055CE01 III
Dima Health Care Boston Scientific Corporation Promus Element Plus OVER-THE-WIRE BTK Everolimus-Eluting Stent System Refer to document attached 3807055CE01 III
Dima Health Care Smith & Nephew Inc Bioraptor 2.9 Suture Anchor 3138 Refer to document attached CE-507064+FQA N.B: 0086 BSI III
Dima Health Care Sofradim Parietex Mesh Refer to document attached 10090 LNE 0459 II b
Dima Health Care Stryker Neurovascular Guglielmi Detachable Coils (GDC) Refer to document attached (1) Refer to document attached (2) CE-3805987DE03 DEKRA III
Dima Health Care Boston Scientific Corporation Neuroform Microdelivery Stent System Refer to document attached (1) Refer to document attached (2) CE-3805987DE06 DEKRA III
Dima Health Care Stryker Neurovascular Target Detachable Coils Refer to document attached (1) Refer to document attached (2) Refer to document attached (3) CE-3805987DE09 DEKRA FQA III
Dima Health Care Boston Scientific Corporation Wingspan Stent System M003WE0xx0xx0 FQA: 3805987CE01 CE- 3805987DE07 III
PTS Meril GmbH Eluting Coronary Stent - BIOMINE Refer to document attached CE- 120302 QS/NB (NB: 1023 ) III
PTS Fimed (IFA Medical) IFABOND IB , IB+, IB05 CE-0944394-01 (NB:0449) III
PTS Eurocor GmbH Eluting Coronary Stent - Genius Taxcor I Refer to document attached CE-1434-MDD-24/2012 Des.Ex. III
PTS Eurocor GmbH Genius Magic Refer to document attached CE-7/11/02538 N.B 0481 III
PTS Chemence Medical Products Inc Dermaflex 107447D501 CE-98334 Q.A N.B BSI II a
PTS Microline Surgical Inc Visuloc 2001/2001 SH FDA 21113-2-2013 II b
PTS Microline Surgical Inc Gemini Clip Cartridge 1113L/ 1133L/ 1114/ 1144 FDA-21113-2-2013 II b
PTS Microline Surgical Inc M/L - 10 Clip Cartridge 1112/1122 FDA-21113-2-2013 II b
Biomedic s.a.r.l CID s.p.a CRE8- Eluting Coronary Stent Refer to document attached 201107130341012CT III
Biomedic s.a.r.l CID s.p.a Coronary Stent - Avantgarde CHRONO Refer to document attached CE-201012090341038 CT III
Biomedic s.a.r.l CID s.p.a Renal Stent- Radix 2 Refer to document attached CE- 201012090341054 CT III
Biomedic s.a.r.l CID s.p.a Peripheral Stent-Isthmus Logic Refer to document attached CE- 20110307034100415 CT III
Biomedic s.a.r.l Aspide SurgiMesh 41515P, 53030P, 2812P FQA 8363 II b
Biomedic s.a.r.l Aspide SurgiMesh PET P3X1015 FQA 8363 II b
Biomedic s.a.r.l Perouse Vascular Graft-POLYMAILLE FLOW Refer to document attached FQA - 19051 II b
Biomedic s.a.r.l Perouse Polymaille Flow+Heparin PFHTR0680, PFHTR0880 FQA - 19051 II b
Promedz Medtronic Trading NLBV Complete SE 3712 Refer to document attached Full Quality assurance II b
Promedz Medtronic Trading NLBV Hippocampus 2889 Refer to document attached Full Quality assurance II b
Promedz Medtronic Trading NLBV Maris Plus 2888 Refer to document attached CE-G1101057794005 II b
Promedz Medtronic Trading NLBV Scuba 2872 Refer to document attached Not Found II b
Promedz Medtronic Trading NLBV InPact Falcon 2937 Refer to document attached CE- 570282 BSI III
Promedz Medtronic Trading NLBV InPact Amphirion 2900 Refer to document attached CE- 570279 III
Promedz Medtronic Trading NLBV InPact Admiral 2919 Refer to document attached CE- 570280 III
Promedz Cyberonics Europe BVBA VNS Therapy Demipulse Model 103 Refer to document attached CE- 84686 CE 01 III
Promedz Stentys SAS Coronary Stent System Refer to document attached CE- 252823 III
Promedz Translumina GmbH YukonCC 3671 Refer to document attached CE-2013-MDDIDE-003 III
Promedz Cyberonics Europe BVBA VNS Therapy Demipulse Model 102 Refer to document attached CE-84686DE08 KEMA Quality III
Intermedic Ethicon/ J&J Surgicel (Snow) .2081. CFG 257-1-2013 III
Intermedic Ethicon/ J&J Surgicel (Snow) .2082. CFG 257-1-2013 III
Intermedic Ethicon/ J&J Surgicel (Snow) .2083. CFG 257-1-2013 III
Intermedic Ethicon/ J&J Surgicel (Fibrillar absorbable) .1963. CFG 257-1-2013 III
Intermedic Ethicon/ J&J Surgicel (Fibrillar absorbable) .1961. CFG 257-1-2013 III
Intermedic Ethicon/ J&J Surgicel (Fibrillar absorbable) .1962. CFG 257-1-2013 III
Intermedic Ethicon/ J&J Surgicel (NU KUNIT) .1940. CFG 257-1-2013 III
Intermedic Ethicon/ J&J Surgicel (NU KUNIT) .1943. CFG 257-1-2013 III
Intermedic Ethicon/ J&J Surgicel (NU KUNIT) .1946. CFG 257-1-2013 III
Intermedic Ethicon/ J&J Surgicel (NU KUNIT) .1941. CFG 257-1-2013 III
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation (Stapler) CDH21/ CDH25/ CDH29/ CDH29A/ CDH33/ CDH 33A CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation (Stapler) ECS25/ECS29/ ECS33/ CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation (Stapler Reloads) CR40B/ CR40G/ CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation (Stapler Reloads) 6R45B CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation (Stapler Reloads) ECR45B/ ECR45D/ ECR45G/ ECR45W CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation ECR60D/ ECR60G/ ECR60T/ ECR60W CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation SR55 CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation TR35W/ TR45B/ TR45G/ TR45W CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation TR60/TR90/ TRV30 CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation TR60B/ TR60G/ TR60W CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation TRD75/ TRT75/ TRV 55/ XR30B/ XR30V/ XR60B/XR60G CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation EL5ML/ EMS CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation ER320/ ER420 CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation LT100/ LT200/ LT300/ LT400/ MCL20/ MCM20/ MCM30/ MCS20/ MSM20 CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation PMW35 CFG- 20388-1-2013 II b
Intermedic J&J Ethicon Endosurgery Endo-surgery ligation PPH01/ PPH03 CFG- 816-2-2012 II b
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