DEVICES THAT IMPLANTED INTO THE BODY TO COMPENSATE FOR THE SHORTCOMINGS DEFECT BODIES OR PHYSICAL DEFECT STENTS FOR PERIPHERAL VESSELS NEPTUN WITH DELIVERY SYSTEM ZSTP7X60351 1 0 1 PCS ZSTP8X60351 1 0 2 PCS SAMOROZSHYRYUYUCHYY STENT JAGUAR WITH THE DELIVERY SYSTEM ZNSJ5X40351 35 2 PCS ZNSJ5X60351 35 1 PC ZNSJ5X80351 35 1 PIECE STENT COBALT CHROMIUM FOR RENAL VESSELS NEFRO C WITH THE DELIVERY SYSTEM ZSTN6X1 81 41 40C 1 PIECE TRADEMARK BALTON MANUFACTURER BALTON SP ZOO UL NOWY SWIAT JULY 1 4 00 496 WARSZAWA POLAND KRAYINAVYROBNYTSTVA PL POLAND ON DISC APPLIED IN ACCORDANCE MARKING AND LABELING CONFORMITY WITH TECHNICAL REGULATIONS IN ACCORDANCE WITH REQUIREMENTS ESTABLISHED BY PKMU 1 1 84 OF 30 1 2 201 5
DEVICES THAT IMPLANTED INTO THE BODY TO COMPENSATE FOR THE SHORTCOMINGS DEFECT BODIES OR PHYSICAL DEFECT STENTS FOR PERIPHERAL VESSELS NEPTUN WITH DELIVERY SYSTEM ZSTP7X60351 1 0 1 PCS ZSTP8X60351 1 0 2 PCS SAMOROZSHYRYUYUCHYY STENT JAGUAR WITH THE DELIVERY SYSTEM ZNSJ5X40351 35 2 PCS ZNSJ5X60351 35 1 PC ZNSJ5X80351 35 1 PIECE STENT COBALT CHROMIUM FOR RENAL VESSELS NEFRO C WITH THE DELIVERY SYSTEM ZSTN6X1 81 41 40C 1 PIECE TRADEMARK BALTON MANUFACTURER BALTON SP ZOO UL NOWY SWIAT JULY 1 4 00 496 WARSZAWA POLAND KRAYINAVYROBNYTSTVA PL POLAND ON DISC APPLIED IN ACCORDANCE MARKING AND LABELING CONFORMITY WITH TECHNICAL REGULATIONS IN ACCORDANCE WITH REQUIREMENTS ESTABLISHED BY PKMU 1 1 84 OF 30 1 2 201 5
1. DEVICES THAT ARE IMPLANTED IN THE BODY TO COMPENSATE FOR THE DEFECT (DEFECT) OF THE ORGAN OR PHYSICAL DEFECT: MEDICAL DEVICES: SELF-EXPANDING STENT MER FOR THE CAROTID ARTERY WITH DELIVERY SYSTEM: ZSTS6X8X3014135 -1PC. ZSTS7X9X4014135 -2 ??. SELF-EXPANDING STENT JEGUAR WITH DELIVERY SYSTEM: ZNSJ9X100356120 -1PC. COBALT-CHROMIUM STENT FOR PERIPHERAL VESSELS NEPTUNE-C WITH DELIVERY SYSTEM AR-EX: ZSTPCRX7X4014140 -2PCS. COBALT-CHROMIUM STENT FOR PERIPHERAL VESSELS NEPTUNE-C WITH DELIVERY SYSTEM OT-DOUBLE: ZSTPCOTW9X6035110 -1PC. BRAND: BALTON MANUFACTURER: BALTON SP. Z OO / BALTON SP. WITH O.O.UL. NOWY SWIAT 7/14 00-496 WARSZAWA POLAND COUNTRY OF MANUFACTURE: PL (POLAND) THE PRODUCT IS MARKED AND CONFORMED TO THE TECHNICAL REGULATIONS IN ACCORDANCE WITH THE REQUIREMENTS ESTABLISHED BY THE PKMU ?1184 DATED 30.12.2015.
1. DEVICES THAT ARE IMPLANTED IN THE BODY TO COMPENSATE FOR THE DEFECT (DEFECT) OF THE ORGAN OR PHYSICAL DEFECT: MEDICAL DEVICES: SELF-EXPANDING STENT MER FOR THE CAROTID ARTERY WITH DELIVERY SYSTEM: ZSTS6X8X3014135 -1PC. ZSTS7X9X4014135 -2 ??. SELF-EXPANDING STENT JEGUAR WITH DELIVERY SYSTEM: ZNSJ9X100356120 -1PC. COBALT-CHROMIUM STENT FOR PERIPHERAL VESSELS NEPTUNE-C WITH DELIVERY SYSTEM AR-EX: ZSTPCRX7X4014140 -2PCS. COBALT-CHROMIUM STENT FOR PERIPHERAL VESSELS NEPTUNE-C WITH DELIVERY SYSTEM OT-DOUBLE: ZSTPCOTW9X6035110 -1PC. BRAND: BALTON MANUFACTURER: BALTON SP. Z OO / BALTON SP. WITH O.O.UL. NOWY SWIAT 7/14 00-496 WARSZAWA POLAND COUNTRY OF MANUFACTURE: PL (POLAND) THE PRODUCT IS MARKED AND CONFORMED TO THE TECHNICAL REGULATIONS IN ACCORDANCE WITH THE REQUIREMENTS ESTABLISHED BY THE PKMU ?1184 DATED 30.12.2015.
20-September-2021
9021909000
1. MEDICAL DEVICES. DEVICES THAT CARRY IMPLANT OR IMPLANT IN THE BODY TO COMPENSATE FOR A DEFECT (DEFECT) OF AN ORGAN OR PHYSICAL DEFECT: CORONARY STENT SYSTEM COATED WITH BIOMATRIX ALPHA 2.25 X 14 MM (MM) CAT.? BMX6-2214-3PCSSTENT- SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 2.25 X 19 MM (MM) CAT. ? BMX6-2219-1PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 2.25 X 24 MM (MM) CAT. ? BMX6-2224-3PCSSTENT SYSTEM CORONARY WITH A COVERING BIOMATRIX ALPHA 2.5 X 19 MM (MM) CAT.? BMX6-2519-7PCSSTENT SYSTEM CORONARY WITH COATING BIOMATRIX ALPHA 2.5 X 24 MM (MM) CAT.? BMX6-2524-1PCSSTENT SYSTEM CORONARY WITH COATING BIOMATRIX ALPHA 2.5 X 29 MM (MM) CAT.? BMX6-2529-4PCSSTENT SYSTEM CORONARY WITH BIOMATRIX ALPHA COATING 2.5 X 36 MM (MM) CAT.? BMX6-2536-1PCSSTENT SYSTEM CORONARY WITH BIOMATRIX ALPHA COATING 2.75 X 14 M CAT .? BMX6-2714-2PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 2.75 X 19 MM (MM) CAT.? BMX6-2719-1PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 2.75 X 24MM (MM) CAT.? BMX6- 2724-3PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 3 X 29 MM (MM) CAT.? BMX6-3029-5PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 3 X 36 MM (MM) CAT.? BMX6-3036-3PCSSTENT- SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 3.5 X 19 MM (MM) CAT. ? BMX6-3519-3PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 3.5 X 24 MM (MM) CAT. ? BMX6-3524-9PCSSTENT SYSTEM CORONARY WITH A COVERING BIOMATRIX ALPHA 3.5 X 29 MM (MM) CAT.? BMX6-3529-1PCSSTENT SYSTEM CORONARY WITH COATING BIOMATRIX ALPHA 3.5 X 33 MM (MM) CAT.? BMX6-3533-1PCSSTENT SYSTEM CORONARY WITH COATING BIOMATRIX ALPHA 3.5 X 36 MM (MM) CAT.? BMX6-3536-3PCSSTENT SYSTEM CORONARY WITH BIOMATRIX ALPHA COATING 2.5 X 24 MM (MM) CAT.? BMX6-2524-3PCSSTENT SYSTEM CORONARY WITH BIOMATRIX ALPHA COATING (BIOMATRIX ALPHA DES) - IT IS A COBALT-CHROMIUM PLATFORM WITH A BIODEGRADABLE POLYMER COATING. THE DRUG-ELUTING STENT IS A COMBINATION PRODUCT CONSISTING OF TWO MAIN COMPONENTS: A STENT (CONTAINING THE ACTIVE DRUG BIOLIMUS A9 ™ (BA9 ™) INCLUDED IN THE POLYMER COATING) AND A DELIVERY SYSTEM. TRADEMARK: BIOMATRIX ALPHAMANUFACTURER: BIOSENSORS EUROPE SA. RUE DE LAUSANNE 29 1110 MORGES SWITZERLAND: PLACE OF PRODUCTION: BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD. 36 JALAN TUKANG SINGAPORE 619266COUNTRY OF PRODUCTION: SG.
1. MEDICAL DEVICES. DEVICES THAT CARRY IMPLANT OR IMPLANT IN THE BODY TO COMPENSATE FOR A DEFECT (DEFECT) OF AN ORGAN OR PHYSICAL DEFECT: CORONARY STENT SYSTEM COATED WITH BIOMATRIX ALPHA 2.25 X 14 MM (MM) CAT.? BMX6-2214-3PCSSTENT- SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 2.25 X 19 MM (MM) CAT. ? BMX6-2219-1PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 2.25 X 24 MM (MM) CAT. ? BMX6-2224-3PCSSTENT SYSTEM CORONARY WITH A COVERING BIOMATRIX ALPHA 2.5 X 19 MM (MM) CAT.? BMX6-2519-7PCSSTENT SYSTEM CORONARY WITH COATING BIOMATRIX ALPHA 2.5 X 24 MM (MM) CAT.? BMX6-2524-1PCSSTENT SYSTEM CORONARY WITH COATING BIOMATRIX ALPHA 2.5 X 29 MM (MM) CAT.? BMX6-2529-4PCSSTENT SYSTEM CORONARY WITH BIOMATRIX ALPHA COATING 2.5 X 36 MM (MM) CAT.? BMX6-2536-1PCSSTENT SYSTEM CORONARY WITH BIOMATRIX ALPHA COATING 2.75 X 14 M CAT .? BMX6-2714-2PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 2.75 X 19 MM (MM) CAT.? BMX6-2719-1PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 2.75 X 24MM (MM) CAT.? BMX6- 2724-3PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 3 X 29 MM (MM) CAT.? BMX6-3029-5PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 3 X 36 MM (MM) CAT.? BMX6-3036-3PCSSTENT- SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 3.5 X 19 MM (MM) CAT. ? BMX6-3519-3PCSSTENT SYSTEM CORONARY WITH A COVERING OF BIOMATRIX ALPHA 3.5 X 24 MM (MM) CAT. ? BMX6-3524-9PCSSTENT SYSTEM CORONARY WITH A COVERING BIOMATRIX ALPHA 3.5 X 29 MM (MM) CAT.? BMX6-3529-1PCSSTENT SYSTEM CORONARY WITH COATING BIOMATRIX ALPHA 3.5 X 33 MM (MM) CAT.? BMX6-3533-1PCSSTENT SYSTEM CORONARY WITH COATING BIOMATRIX ALPHA 3.5 X 36 MM (MM) CAT.? BMX6-3536-3PCSSTENT SYSTEM CORONARY WITH BIOMATRIX ALPHA COATING 2.5 X 24 MM (MM) CAT.? BMX6-2524-3PCSSTENT SYSTEM CORONARY WITH BIOMATRIX ALPHA COATING (BIOMATRIX ALPHA DES) - IT IS A COBALT-CHROMIUM PLATFORM WITH A BIODEGRADABLE POLYMER COATING. THE DRUG-ELUTING STENT IS A COMBINATION PRODUCT CONSISTING OF TWO MAIN COMPONENTS: A STENT (CONTAINING THE ACTIVE DRUG BIOLIMUS A9 ™ (BA9 ™) INCLUDED IN THE POLYMER COATING) AND A DELIVERY SYSTEM. TRADEMARK: BIOMATRIX ALPHAMANUFACTURER: BIOSENSORS EUROPE SA. RUE DE LAUSANNE 29 1110 MORGES SWITZERLAND: PLACE OF PRODUCTION: BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD. 36 JALAN TUKANG SINGAPORE 619266COUNTRY OF PRODUCTION: SG.
01-August-2019
9021909000
1. DEVICES AND DEVICES USED IN MEDICINE ARE INTENDED FOR IMPLANTATION IN THE BODY TO COMPENSATE FOR PHYSICAL DEFECTS: ART.SPCBC35140060038 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW0.035 ' 6X38 MM LENGTH 140 CM - 1PC; ART. SPCBC35140060058 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW 0.035 ' 6?58 MM LENGTH 140 CM - 1 PIECE; ART.SPCBC35140070018 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW0.035' 7?18 MM LENGTH 140 CM - 2 PIECES; .SPCBC35140070028 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW 0.035 ' 7X28 MM LENGTH 140 CM - 2PCS; ART.SPCBC35140070038 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW0.035' 7X38 MM LENGTH 140 CM - 3PCS; ART.SPCBC35140070058 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW 0.035 ' 7?58 MM LENGTH 140 CM - 2 PIECES; ART.SPCBC35140080018 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW0.035' 8?18 MM LENGTH 140 CM - 2 PIECES ART.SPCBC35140080028 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW 0.03 5
1. DEVICES AND DEVICES USED IN MEDICINE ARE INTENDED FOR IMPLANTATION IN THE BODY TO COMPENSATE FOR PHYSICAL DEFECTS: ART.SPCBC35140060038 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW0.035 ' 6X38 MM LENGTH 140 CM - 1PC; ART. SPCBC35140060058 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW 0.035 ' 6?58 MM LENGTH 140 CM - 1 PIECE; ART.SPCBC35140070018 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW0.035' 7?18 MM LENGTH 140 CM - 2 PIECES; .SPCBC35140070028 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW 0.035 ' 7X28 MM LENGTH 140 CM - 2PCS; ART.SPCBC35140070038 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW0.035' 7X38 MM LENGTH 140 CM - 3PCS; ART.SPCBC35140070058 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW 0.035 ' 7?58 MM LENGTH 140 CM - 2 PIECES; ART.SPCBC35140080018 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW0.035' 8?18 MM LENGTH 140 CM - 2 PIECES ART.SPCBC35140080028 COBALT-CHROME PERIPHERAL STENT SYSTEM RESTORER GW 0.03 5
20-September-2021
9021909000
1. MEDICAL DEVICES. DEVICES WORN CARRIED OR IMPLANTED IN THE BODY TO COMPENSATE FOR AN ORGAN DEFECT OR PHYSICAL DEFECT: CHROMA CORONARY STENT SYSTEM 2.25 X 14 MM (MM) CAT. ? BCR-2214-1PCSSTENT SYSTEM CORONARY CHROMA 2 25 X 19 MM (MM) CAT. R BCR-2219-1PCSSTENT SYSTEM CORONARY CHROMA 2 25 X 29 MM (MM) CAT. ? BCR-2229-1PCSSTENT SYSTEM CORONARY CHROMA 2 5 X 29 MM (MM) CAT.? BCR-2529-3PCSSTENT SYSTEM CORONARY CHROMA 2 5 X 33 MM (MM) CAT.? BCR-2533-2PCSSTENT SYSTEM CORONARY CHROMA 2 5 X 36 MM (MM) CAT. ? BCR-2536-2PCSSTENT SYSTEM CORONARY CHROMA 2 75 X 29 MM (MM) CAT. ? BCR-2729-3PCSSTENT SYSTEM CORONARY CHROMA 2 75 X 33 MM (MM) CAT. ? BCR-2733 -1PCSTENT SYSTEM CORONARY CHROMA 3 0 X 33 MM (MM) CAT. R BCR-3033-5PCSSTENT SYSTEM CORONARY CHROMA 3 0 X 36 MM (MM) CAT.? BCR-3036-3PCSSTENT SYSTEM CORONARY CHROMA IS A HOLOMETALLIC STENT (HMS) SYSTEM DESIGNED FOR USE IN THE CORONARY ARTERIES WHICH CONSISTS OF A COBALT-CHROMIUM PLATFORM MOUNTED ON A BALLOON AND CONNECTED DELIVERY SYSTEMS.BRAND: CHROMAMANUFACTURER: BIOSENSORS EUROPE SA. RUE DE LAUSANNE 29 1110 MORGES SWITZERLAND: PLACE OF PRODUCTION: BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD. 36 JALAN TUKANG SINGAPORE 619266COUNTRY OF PRODUCTION: SG.
1. MEDICAL DEVICES. DEVICES WORN CARRIED OR IMPLANTED IN THE BODY TO COMPENSATE FOR AN ORGAN DEFECT OR PHYSICAL DEFECT: CHROMA CORONARY STENT SYSTEM 2.25 X 14 MM (MM) CAT. ? BCR-2214-1PCSSTENT SYSTEM CORONARY CHROMA 2 25 X 19 MM (MM) CAT. R BCR-2219-1PCSSTENT SYSTEM CORONARY CHROMA 2 25 X 29 MM (MM) CAT. ? BCR-2229-1PCSSTENT SYSTEM CORONARY CHROMA 2 5 X 29 MM (MM) CAT.? BCR-2529-3PCSSTENT SYSTEM CORONARY CHROMA 2 5 X 33 MM (MM) CAT.? BCR-2533-2PCSSTENT SYSTEM CORONARY CHROMA 2 5 X 36 MM (MM) CAT. ? BCR-2536-2PCSSTENT SYSTEM CORONARY CHROMA 2 75 X 29 MM (MM) CAT. ? BCR-2729-3PCSSTENT SYSTEM CORONARY CHROMA 2 75 X 33 MM (MM) CAT. ? BCR-2733 -1PCSTENT SYSTEM CORONARY CHROMA 3 0 X 33 MM (MM) CAT. R BCR-3033-5PCSSTENT SYSTEM CORONARY CHROMA 3 0 X 36 MM (MM) CAT.? BCR-3036-3PCSSTENT SYSTEM CORONARY CHROMA IS A HOLOMETALLIC STENT (HMS) SYSTEM DESIGNED FOR USE IN THE CORONARY ARTERIES WHICH CONSISTS OF A COBALT-CHROMIUM PLATFORM MOUNTED ON A BALLOON AND CONNECTED DELIVERY SYSTEMS.BRAND: CHROMAMANUFACTURER: BIOSENSORS EUROPE SA. RUE DE LAUSANNE 29 1110 MORGES SWITZERLAND: PLACE OF PRODUCTION: BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD. 36 JALAN TUKANG SINGAPORE 619266COUNTRY OF PRODUCTION: SG.