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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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