| Blazejewski
|
Germany
|
102 others
|
IIa
93/42
|
Website
info@blazejewski.de
EUDAMED record
Report an error
|
| Tianjin Bolang Science-Technology Development
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
84 others
|
IIa
93/42
|
EUDAMED record
Report an error
|
| Olympus Winter & Ibe FDA
|
Germany
|
83 others- Guiding tube, for probes93/42
- Guiding tube, for probes, with retractor93/42
- Inner sheath, for 26 Fr. outer sheath93/42
- Inner sheath, for 26 Fr. outer sheath, with A22085A93/42
- Inner sheath, long, for WA22018A and WA22019A93/42
- Inner sheath, long, for WA22018A/19A, with deflecting tip obturator93/42
- Irrigation port, 1 Luer-Lock connector, rotatable93/42
- Irrigation port, 1 stopcock, rotatable93/42
- Irrigation port, 1 vertical stopcock, fixed93/42
- Irrigation port, 2 stopcocks, rotatable93/42
- Obturator 17 Fr.3 refs
- Obturator optical, 19.8 Fr.93/42
- Obturator optical, 21 Fr.93/42
- Obturator optical, 22.5 Fr.93/42
- Obturator optical, 25 Fr.93/42
- Obturator, 15.5 Fr., for A20930A93/42
- Obturator, 17 Fr., for A20911A93/42
- Obturator, 19.8 Ch., for A20916A93/42
- Obturator, 19.8 Fr, for A20912A93/42
- Obturator, 21 Fr., for A20913A93/42
- Obturator, 21 Fr., for A20933A93/42
- Obturator, 22.5 Fr., for A20914A/-34A93/42
- Obturator, 24 Fr.93/42
- Obturator, 25 Fr.93/42
- Obturator, 26 Fr.93/42
- Obturator, 5 mm93/42
- Obturator, deflecting tip, 24 Fr.93/42
- Obturator, deflecting tip, 26 Fr.93/42
- Obturator, for A3551, 4 Fr. channel93/42
- Obturator, optical, 24 Fr.93/42
- Obturator, optical, 24 Fr., long93/42
- Obturator, optical, 26 Fr.93/42
- Obturator, optical, for A42021A93/42
- OP telescope, 0°, 5 mm channel93/42
- OP telescope, 7°, 11 Fr. x 220 mm, 7.5 Fr. channel, angled ocular93/42
- OP-telescope, 30°, 4 mm channel93/42
- Outer sheath, 26 Fr., 2 stopcocks, rotatable93/42
- Outer sheath, 26 Fr., 2 stopcocks, vertical, fixed93/42
- Outer sheath, 26 Fr., for A355193/42
- Outer sheath, 27 Fr, 2 stopcocks, vertical, fixed93/42
- Outer sheath, 27 Fr., 2 stopcocks, rotatable93/42
- Outer sheath, 27 Fr., long, rotatable93/42
- Outer sheath, 27 Fr., long, rotatable, for tumor resection93/42
- Outer sheath, 28 Fr., 2 stopcocks, rotatable93/42
- Outer sheath, 8.5 mm / 26 Fr., 2 stopcocks, rotatable93/42
- Resection sheath, 24 Fr.93/42
- Resection sheath, 24 Fr., with deflecting obturator93/42
- Resection sheath, 26 Fr.93/42
- Resection sheath, 26 Fr., with deflecting obturator93/42
- Resection sheath, 8 mm, for 8.5 mm outer sheath93/42
- Sheath, 22 Fr., for urethrotome93/42
- Sheath, 3.0 mm93/42
- Sheath, 4 mm93/42
- Sheath, 4.5 mm, 5 Fr. channel, continuous irrigation93/42
- Sheath, 4.5 mm, continuous irrigation, 3 Fr. channel93/42
- Sheath, 5 mm93/42
- Sheath, 5.5 mm, 5 Fr. channel, continuous irrigation93/42
- Sheath, 5.5 mm, continuous irrigation, 3 Fr. channel93/42
- Sheath, 6.5 mm, continuous flow, 5 Fr. channel93/42
- Sheath, 6.5 mm, continuous irrigation, 7 Fr. channel93/42
- Telescope, 3 mm, 0°, autoclavable93/42
- Telescope, 3 mm, 12°, autoclavable93/42
- Telescope, 3 mm, 30°, wideangle, autoclavable93/42
- Telescope, 4 mm, 0°, HD, autoclavable OES ELITE93/42
- Telescope, 4 mm, 12 °, PDD, HD, autoclavable OES ELITE93/42
- Telescope, 4 mm, 12°, HD, autoclavable OES ELITE93/42
- Telescope, 4 mm, 12°, long93/42
- Telescope, 4 mm, 30 °, PDD, HD, autoclavable OES ELITE93/42
- Telescope, 4 mm, 30 °, wide-angle, HD, autoclavable OES ELITE93/42
- Telescope, 4 mm, 30°, HD, autoclavable OES ELITE93/42
- Telescope, 4 mm, 70 °, PDD, HD, autoclavable OES ELITE93/42
- Telescope, 4 mm, 70°, HD, autoclavable OES ELITE93/42
- Telescope, 4 mm, 70°, long93/42
- Working element, active93/42
- Working element, active, for resection in saline93/42
- Working element, for A355193/42
- Working element, for probes93/42
- Working element, passive93/42
- Working element, passive, for resection in saline93/42
- Working insert, 24 Fr., 6 Fr. channel93/42
- Working insert, 8.5 mm, 8 Fr. channel, for A42021A93/42
- Telescope, 1.9 mm, 0°, 280mm, autoclavable93/42 (no longer marketed)
- Telescope, 1.9 mm, 30°, 280 mm, autoclavable93/42 (no longer marketed)
|
I, IIa, IIb
MDR, 93/42
|
Website
eudamed.regulatoryaffairs@olympus-oste.eu
EUDAMED record
Report an error
|
| Erbe Vision FDA
|
Germany
|
32 others- Hysteroscope, autoclavable, Ø 2.9mm; 0° HD; WL 300mm 20862-XXX93/42
- Hysteroscope, autoclavable, Ø 2.9mm; 12° HD; WL 300mm 20862-XXX93/42
- Hysteroscope, autoclavable, Ø 2.9mm; 30° HD; WL 300mm 20862-XXX93/42
- Hysteroscope, autoclavable, Ø 4mm; 0° HD; WL 300mm 20862-XXX93/42
- Hysteroscope, autoclavable, Ø 4mm; 12° HD; WL 300mm 20862-XXX93/42
- Hysteroscope, autoclavable, Ø 4mm; 30° HD; WL 300mm 20862-XXX93/42
- Hysteroscope, autoclavable, Ø 4mm; 70° HD; WL 300mm 20862-XXX93/42
- Inner sheath, cont.flow, diag. Ø 5.4mm; WL 260mm;for Ø 4mm 0° 20862-XXX93/42
- Inner sheath, cont.flow, diag. Ø 5.4mm;WL 260mm;for Ø 4mm 30° 20862-XXX93/42
- Inner sheath, diagnostic, Ø 4mm; WL 260mm; f. Ø2.9mm 30° 20862-XXX93/42
- Inner sheath, diagnostic, Ø 4mm; WL 260mm; for Ø2.9mm 0° 20862-XXX93/42
- Inner sheath, operating, for Ø 2,9mm 30° 20862-XXX93/42
- Inner sheath, operating, for Ø2.9mm 20862-XXX93/42
- Inner sheath, operating, sem-rig 5CH instrument channel 20862-XXX93/42
- Inner sheath, resectoscope, 24CH; for Ø 4mm 20862-XXX93/42
- Inner sheath,resectoscope,mini 17.5CH; for Ø 2.9mm 20862-XXX93/42
- Outer sheath, cont.flow, diag. Ø5mm;WL 240mm;f. Ø2.9mm 0°&30° 20862-XXX93/42
- Outer sheath, cont.flow, diag. Ø6.5mm;WL 240mm;f. Ø4mm 0°&30° 20862-XXX93/42
- Outer sheath, cont.flow, oper. Ø 6.3mm; WL 192mm; for Ø 2.9mm 20862-XXX93/42
- Outer sheath, cont.flow, oper. Ø 6.5mm;WL 192mm;for Ø 4mm 30° 20862-XXX93/42
- Outer sheath, resectoscope, round holes, 26CH; for Ø 4mm 20862-XXX93/42
- Outer sheath,resectoscope,mini cont.flow., 18.5CH;for Ø2.9mm 20862-XXX93/42
- Sheath for resectoscope, oblique tip, 24 CH 20862-XXX93/42
- Sheath, cont. flow, operating, Ø 8mm; WL 200mm;for Ø 4mm 0° 20862-XXX93/42
- Sheath, cont. flow, operating, Ø 8mm; WL 200mm;for Ø 4mm 30° 20862-XXX93/42
- Sheath,single flow,diagnostic Ø 4mm; WL 270mm; f. Ø2.9mm 30° 20862-XXX93/42
- Sheath,single flow,diagnostic Ø 4mm; WL 270mm; for Ø2.9mm 0° 20862-XXX93/42
- Working element bip. ,active, 26/24CH, w. protection rod 20862-XXX93/42
- Working element bip. ,passive, 26/24CH, w. protection rod 20862-XXX93/42
- Working element mono.,active, 26/24CH, w. protection rod 20862-XXX93/42
- Working element mono.,passive, 26/24CH, w. protection rod 20862-XXX93/42
- Working element, mini, bipolar passive,18.5CH 20862-XXX93/42
|
I, IIa, IIb
MDR, 93/42
|
Website
info.vision.de@erbegroup.com
EUDAMED record
Report an error
|
| STEMA Medizintechnik
|
Germany
|
24 others
|
IIb
93/42
|
Website
info@stema-medizintechnik.de
EUDAMED record
Report an error
|
| Hologic FDA
EU representative : Hologic BV (Belgium)
|
United States
|
12 others
|
IIa
93/42
|
EUDAMED record
Report an error
|
| Richard Wolf FDA
|
Germany
|
9 others
|
I, IIa
MDR, 93/42
|
info@richard-wolf.com
EUDAMED record
Report an error
|
| Karlstorz FDA
|
Germany
|
7 others- Sheaths, irrigation/suction, nephroscopy
- Sheaths, nephroscopy
- Telescopes, hysteroscopy2 refs
- Telescopes, irrigation, hysteroscopy
- Telescopes, urology3 refs
- Telescopes, urology, natural body orifices3 refs
- Telescopes, working channel, metal2 refs
|
IIa
MDR
|
Website
regulatory@karlstorz.com
EUDAMED record
Report an error
|
| Hangzhou Hawk Optical Electronic Instruments FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
- Adaptateur poire d'Ellik PG-VA, PG-VB,PG-VC,XPG-II, PPS-II, DS-II, SS-II, NS-II, NQ-II, XNQ-I3 refs
- Cystoscope numérique 12.5CH DPG-I, DPG-III3 refs
- Nefroscopio93/42
- Nefroscopio F893/42
- Nephroscopes SN-IV93/42
6 others
|
I, IIa
MDR, 93/42
|
Website
EUDAMED record
Report an error
|
| Guangzhou Red Pine Medical Instrument FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
- RP-U-C0101
- RP-U-C0202, RP-U-C0202S2 refs
- RP-U-C03R9, RP-U-C03S9, RP-U-C03R3, RP-U-C03S3, RP-U-C04R9, RP-U-C04S9, RP-U-C04R3, RP-U-C04S3, RP-U-C06R9, RP-U-C06S9, RP-U-C06R3, RP-U-C06S3, RP-U-C06BR9, RP-U-C06BS9, RP-U-C06BR3, RP-U-C06BS33 refs
- RP-U-C0410
- Single-Use Video Flexible Cysto-Nephroscope RP-U-C01F, RP-U-C01FS, RP-U-C01E, RP-U-C01ES, ASUS-HD-15R-CYS-02, ASUS-HD-15S-CYS-023 refs
4 others- Single-Use Video Flexible Cystoscope RP-U-C0201, RP-U-C0201S2 refs
- Single-Use Video Flexible Ureterorenoscope RP-U-C0306F, RP-U-C0307F, RP-U-C0306FS9, RP-U-C0307FS93 refs
- Single-Use Video Flexible Ureterorenoscope RP-U-C12, RP-U-C0304, RP-U-C0305, RP-U-C12S3, RP-U-C12S9, RP-U-C12R3, RP-U-C0304S3, RP-U-C0304S9, RP-U-C0304R3, RP-U-C0305S3, RP-U-C0305S9, RP-U-C0305R3, RP-U-C12., RP-U-C12K, RP-U-C0305B3 refs
- Single-Use Video Hysteroscope RP-G-C24, RP-G-C0101, RP-G-C0101B3 refs
|
IIa
MDR
|
Website
regulation@gzredpine.com
EUDAMED record
Report an error
|
| Gimmi FDA
|
Germany
|
2 others
|
IIa
93/42
|
Website
EUDAMED record
Report an error
|
| Seesheen
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
2 others
|
IIa
MDR, 93/42
|
Website
EUDAMED record
Report an error
|
| Covidien FDA
EU representative : Medtronic B.V. (Netherlands)
|
United States
|
1 other
|
I, IIa
MDR
|
EUDAMED record
Report an error
|
| Zhuhai Vision Medical Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
1 other
|
IIa
MDR
|
service@vision-medt.com
EUDAMED record
Report an error
|
| Alltion FDA
EU representative : Obelis s.a. (Belgium)
|
China
|
|
I
MDR
|
Website
sales@alltion.com
EUDAMED record
Report an error
|
| Amnotec
|
Germany
|
|
I, IIa, IIb
MDR
|
Website
EUDAMED record
Report an error
|
| Mindray FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
- Rigid Endoscope M 00430A, G 00430A, M 00412A, G 00412A, M 02930A, G 02930A, M 02912A, G 02912A, M 00430PA, G 00430PA, M 00412PA, G 00412PA, M 02930PA, G 02930PA, M 02912PA, G 02912PA3 refs
- Rigid Endoscope M 00430A/ M 02930A/ G 00430A/ G 02930A, G S041601H / G S291401H, G S042000H / G S291600H, G C042000H / G C291600H3 refs
- Rigid Endoscope M 02900A, M 02930A, G 02900A, G 02930A, M 02900PA, M 02930PA, G 02900PA, G 02930PA, M 00400A, M 00430A, M 00470A, G 00400A, G 00430A, G 00470A, M 00400PA, M 00430PA, M 00470PA, G 00400PA, G 00430PA, G 00470PA3 refs
- Single-Use Cysto-Nephroscope FCY08-L069BAF, FCY07-L070BAF, FCY08-L069PAF, FCY07-L070PAF, FCY14-M040MBF, FCY16-M040MBF, FCY14-M041PBF, FCY16-M041PBF, FCY14-M040PBR, FCY16-M040PBR3 refs
- Single-Use Ureteroscope FUR08-L068BBF, FUR08-L069BBF, FUR08-L070BBF, FUR08-L070BBR, FUR08-L068NBF, FUR08-L069NBF, FUR08-L070MBF, FUR08-L070MBR, FUR08-L068PBF, FUR08-L069PBF, FUR08-L070PBF, FUR08-L070PBR3 refs
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| Scivitamedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
- Single-use Flexible Ureteroscope SUV-(1A-B,1A-P,2A-B,2A-P,2B-B,2B-P,2C-B,2C-P,3A-B,3C-B,4A-B,4C-B,1A-BF, 2A-BF, 2B-BF, 2C-BF, 3C-BF, 4C-BF, 1F-BF, 2F-BF), SUVB-(1F-BF , 2F-BF),SUVC-(1F-BF, 2F-BF), SUVG-(1F-BF, 2F-BF),SUVI-1F-BF, SUVE-1F-BF3 refs
- Single-use Flexible Cystoscope SUV-1D-B, SUV-1D-P, SUV-3D-B, SUV-4D-B3 refs
- Single-use Hystero Videoscope SHV-4800, SHV-6800, SHV-4830, SHV-4830L, SHV-4830N, SHV-4830LN, SHV-6830, SHV-6830L, SHV-6830N, SHV-6830LN, SHV-5830, SHV-5830L, SHV-5830N, SHV-5830LN3 refs
- Single-use Hystero Videoscope SHV-B1,SHV-P1,SHV-B2,SHV-P23 refs
- Single-use Hystero Videoscope SHV-S1,SHV-S22 refs
|
IIa
MDR
|
Website
info@scivitamedical.com
EUDAMED record
Report an error
|
| Zhenjiang Excellence Medical Tech
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
I
MDR
|
EUDAMED record
Report an error
|
| Adamosrl
|
Italy
|
|
I
MDR
|
Website
info@adamosrl.com
EUDAMED record
Report an error
|
| Cogentix Medical FDA
EU representative : Medical Measurement Systems B.V. (Netherlands)
|
United States
|
|
IIa
93/42
|
EUDAMED record
Report an error
|
| Hugemed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
- CY-M52,CY-M50,CY-M40,CY-M32,CY-M52H,CY-M40H3 refs
- HU32
- HugeMed HU30,HU30S,HU30M2 refs
- HugeMed HY-45A, HY-45B, HY-50A, HY-50B3 refs
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Mercury Produzione
|
Italy
|
|
I, IIa
MDR, 93/42
|
Website
EUDAMED record
Report an error
|
| Seegen FDA
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
- UV-100-E,UV-110-E,UV-100T-E,UV-110T-E,UV-US100N-E3 refs
- UV-US100-H,UV-US110-H,UV-US120-H,UV-US130-H,UV-US100X-H,UV-US100D-H, UV-US120-H-3U, UV-US130-H-3U, UV-US100D-H-3U3 refs
- UV-US100S-H, UV-US110S-H, UV-US100TS-H, UV-US110DS-H, UV-US120DS-H, UV-US121S-H, UV-US130S-H, UV-US140S-H, UV-US150S-H3 refs
- UV-US121-H, UV-US101D-H, UV-US140-H, UV-US140-H-3U, UV-US100T-H, UV-US100T-H-3U, UV-US110T-H, UV-US110T-H-3U, UV-US110D-H, UV-US110D-H-3U, UV-US150-H, UV-US150-H-3U, UV-US120D-H3 refs
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| Shenyang Shenda Endoscope FDA
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
|
China
|
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| Alton FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
IIa
MDR
|
info@alton.com.cn
EUDAMED record
Report an error
|
| Ambu FDA
|
Denmark
|
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| Besdatatech FDA
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
- Single use flexible cystoscope CY-D1,CY-F1,CY-F2,CY-F33 refs
- Single use flexible ureteroscope UR-D1,UR-D2,UR-F1,UR-F2,UR-F3,UR-F4,UR-F5,UR-F6,UR-F8,UR-F93 refs
- Single use hysteroscope HY-H1,HY-H2,HY-G1,HY-G2,HY-H3,HY-H4,HY-H5,HY-H6,HY-H73 refs
|
IIa
MDR
|
support@besdatatech.com
EUDAMED record
Report an error
|
| Biomedicinos technika
|
Lithuania
|
|
I
MDR
|
EUDAMED record
Report an error
|
| EUSA Global FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
United States
|
|
I
MDR
|
Website
EUDAMED record
Report an error
|
| Himaging FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
- Single-Use Flexible Video Cystoscope DCYS-100HLP, DCYS-100HLPR2 refs
- Single-Use Flexible Video Cystoscope DCYS2-222HP, DCYS2-222HPR, DCYS2-223HP, DCYS2-223HPR3 refs
- Single-use Flexible Video Ureterorenoscope DURS1-121P, DURS1-121PR,DURS1-121PS,DURS1-121PRS,DURS1-120P,DURS1-120PR,DURS1-120PS,DURS1-120PRS3 refs
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Huger FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| Innoview FDA
|
Germany
|
|
IIa
MDR
|
Website
mail@innoview.info
EUDAMED record
Report an error
|
| Labotech Microscopes India
EU representative : Labomed Europe b.v. (Netherlands)
|
India
|
|
I
MDR
|
EUDAMED record
Report an error
|
| MacroLux Medical Technology FDA
EU representative : Wellkang Ltd (Northern Ireland)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Meditrina FDA
EU representative : Advena Limited (Malta)
|
United States
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Nopa FDA
|
Germany
|
|
IIa
MDR
|
Website
info@nopa.de
EUDAMED record
Report an error
|
| Otumed FDA
EU representative : MedNet EC-REP GmbH (Germany)
|
United States
|
- Aptra OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S,3 refs
- WiScope OTU-C300S, OTU-C300R, OTU-C310S, OTU-C310R, OTU-C311S, OTU-C311R, OTU-C380SL, OTU-C380RL, OTU-C380SR, OTU-C380RR, OTU-C320S, OTU-C320R, OTU-C330S, OTU-C330R3 refs
- WiScope OTU-HY01S, OTU-HY01C, OTU-HY02S, OTU-HY02C, OTU-HY03S, OTU-HY03C, OTU-HY04S, OTU-HY04C3 refs
|
IIa
MDR
|
sales@otumed.com
EUDAMED record
Report an error
|
| Pusenmedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
- Clear EVAC PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; PU500-AS, PU500-AR, PU501-AS, PU501-AR; PU630A-S, PU630A-R, PU631A-S, PU631A-R;3 refs
- MDH MC1002 refs
- PC200-AS, PC200-AR, PC200-S, PC200-R;3 refs
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| Shanghai Anqing Medical Instrument FDA
EU representative : Emergo Europe B.V. (Netherlands)
|
China
|
|
IIa
MDR
|
ra_dept@anqing-sh.com
EUDAMED record
Report an error
|
| Sonoscape FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
IIa
MDR
|
ra@sonoscape.net
EUDAMED record
Report an error
|
| Zhejiang Geyi Medical Instrument FDA
EU representative : MedPath GmbH (Germany)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Ackermann Instrumente FDA
|
Germany
|
|
I
MDR
|
Website
info@ackermannsurgical.com
EUDAMED record
Report an error
|
| Aohua
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Bissinger FDA
|
Germany
|
|
IIb
93/42
|
Website
info@bissinger.com
EUDAMED record
Report an error
|
| Delmont imaging
|
France
|
|
I, IIa
MDR
|
Website
contact@delmont-imaging.com
EUDAMED record
Report an error
|
| Endoso FDA
EU representative : Umedwings Netherlands B.V. (Netherlands)
|
China
|
- PCS12-1, PCS12-2, PCS12-3, PCS22-1, PCS22-2, PCS22-3, PCS22-4, PCS22-5, PCS22-6, PCS24-1, PCS24-2, PCS24-3, PCS24-4, PCS24-5, PCS24-63 refs
- PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S23 refs
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Ezisurg FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
IIa
MDR
|
Website
ra@ezisurg.com
EUDAMED record
Report an error
|
| Guangxi Visualtech S&T
EU representative : Eunitor GmbH (Germany)
|
China
|
|
I
MDR
|
EUDAMED record
Report an error
|
| Henke-Sass, Wolf FDA
|
Germany
|
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| Hunan Reborn Medical Science Technology Development
EU representative : MedPath GmbH (Germany)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Ningbo Xinwell Medical Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Optomic FDA
|
Spain
|
|
I
MDR
|
Website
prrc@optomic.com
EUDAMED record
Report an error
|
| Schoelly FDA
|
Germany
|
|
IIa
MDR
|
Website
info@schoelly.de
EUDAMED record
Report an error
|
| Tuyunmed
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
IIa
MDR
|
radepartment@tuyunmed.com
EUDAMED record
Report an error
|
| Unimicromed
EU representative : Wellkang Ltd (Northern Ireland)
|
China
|
- UNC-UT25A, UNC-UT25B, UNC-UT25C, UNC-UT25D, UNC-UT25E, UNC-UT31A, UNC-UT31B, UNC-UT31C, UNC-UT31D, UNC-UT31E3 refs
- UNEN-BD50A, UNEN-BD50B, UNEN-BD50C, UNEN-BD50D, UNEN-BD50E3 refs
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| UroViu FDA
EU representative : Casus Europe B.V. (Netherlands)
|
United States
|
|
I
MDR
|
Website
cs@uroviu.com
EUDAMED record
Report an error
|
| Vathin FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
- Models: US01 series: US-S170, US-S180, US-E170, US-E180, US-S170R, US-E170R; US02 series: US-S2600, USE2600, US-S2600R, US-E2600R, US-S2602, US-E2602, USS2602R, US-E2602R3 refs
- Single-use Flexible Cystoscope CY-E2E013 refs
|
IIa
MDR
|
Website
service@vathin.com
EUDAMED record
Report an error
|
| Weseemed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
IIa
MDR
|
info@weseemed.com
EUDAMED record
Report an error
|
| Aesculap FDA
|
Germany
|
|
IIa
MDR
|
Website
eudamed@bbraun.com
EUDAMED record
Report an error
|
| Anhui Happiness Workshop Medical Instruments FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Anhui YODO Biotechnology
EU representative : Kingsmead Service B.V. (Netherlands)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Asieris
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| Atmosmed FDA
|
Germany
|
|
I
MDR
|
Website
info@atmosmed.de
EUDAMED record
Report an error
|
| Axess Vision Technology FDA
|
France
|
|
I
MDR
|
Website
raqa.ptm@tsc-group.com
EUDAMED record
Report an error
|
| Bonreemed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| Boston Scientific FDA
EU representative : Boston Scientific Limited (Ireland)
|
United States
|
|
IIa
MDR
|
Website
eudamed@bsci.com
EUDAMED record
Report an error
|
| Casio
EU representative : MedNet EC-REP GmbH (Germany)
|
Japan
|
|
I
MDR
|
info_prrc1-yam@casio.co.jp
EUDAMED record
Report an error
|
| Centrel
|
Italy
|
|
I
MDR
|
Website
info@centrel.com
EUDAMED record
Report an error
|
| CooperSurgical FDA
EU representative : CooperSurgical Distribution B.V. (Netherlands)
|
United States
|
|
IIa
MDR
|
RA-CSI@coopersurgical.com
EUDAMED record
Report an error
|
| DYSIS Medical
EU representative : DYSIS MEDICAL ΕΜΠΟΡΙΑ ΙΑΤΡΙΚΟΥ ΕΞΟΠΛΙΣΜΟΥ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ (EL)
|
United Kingdom (ex Northern Ireland)
|
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| Edan FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
I
MDR
|
EUDAMED record
Report an error
|
| Endomed
|
Germany
|
|
IIa
MDR
|
Website
info@endomed.com
EUDAMED record
Report an error
|
| Gynius
|
Sweden
|
|
I
MDR
|
Website
info@gynius.se
EUDAMED record
Report an error
|
| Hunan Endovascular Device
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
IIa
MDR
|
Sales@hnevd.com
EUDAMED record
Report an error
|
| Iseemed
EU representative : MedPath GmbH (Germany)
|
China
|
|
IIa
MDR
|
info@iseemed.com
EUDAMED record
Report an error
|
| Jiangsu Jinyuan Medical Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
I
MDR
|
EUDAMED record
Report an error
|
| Jiangsu Jiyuan Medical Technology FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Jiangsu Mole Electronic Technology FDA
EU representative : phoenix Medtech GmbH (Germany)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Kernelmed FDA
EU representative : Caretechion GmbH (Germany)
|
China
|
|
I
MDR
|
EUDAMED record
Report an error
|
| Leisegang
|
Germany
|
|
I
MDR
|
Website
EUDAMED record
Report an error
|
| Liger Medical FDA
EU representative : MedNet EC-REP IIb GmbH (Germany)
|
United States
|
|
I
MDR
|
Website
support@ligermedical.com
EUDAMED record
Report an error
|
| Lutech Industries FDA
EU representative : Arazy Group GmbH (Germany)
|
United States
|
|
I
MDR
|
Website
info@lutechmedical.com
EUDAMED record
Report an error
|
| Medipo
|
Czechia
|
|
I
MDR
|
Website
info@medipo.cz
EUDAMED record
Report an error
|
| Miconvey FDA
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
- Single Use Flexible Ureteroscope EPU-7635, EPU-7640, EPU-7645, EPU-7650, EPU-7655, EPU-7660, EPU-7665, EPU-7670, EPU-7635R, EPU-7640R, EPU-7645R, EPU-7650R, EPU-7655R, EPU-7660R, EPU-7665R, EPU-7670R3 refs
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Micro Instrument
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
India
|
|
I
MDR
|
Website
info@mikoindia.com
EUDAMED record
Report an error
|
| Ningbo Wise OptoMech Technology FDA
EU representative : Prolinx GmbH (Germany)
|
China
|
|
IIa
MDR
|
sales@ws-medical.com
EUDAMED record
Report an error
|
| PROCEPT BioRobotics FDA
EU representative : Qualrep Services B.V. (Netherlands)
|
United States
|
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| RZ-Medizintechnik FDA
|
Germany
|
|
IIa
MDR
|
Website
info@rz-medizintechnik.com
EUDAMED record
Report an error
|
| Scaner
EU representative : AFINA, spol.s r.o. (Czechia)
|
Ukraine
|
|
I
MDR
|
EUDAMED record
Report an error
|
| SCHMITZ medical FDA
|
Germany
|
|
I
MDR
|
Website
EUDAMED record
Report an error
|
| Simai
EU representative : Wellkang Ltd (Northern Ireland)
|
China
|
|
IIa
93/42
|
EUDAMED record
Report an error
|
| Softlinkmed
EU representative : Eunitor GmbH (Germany)
|
China
|
|
I
MDR
|
marketing@softlinkmed.com
EUDAMED record
Report an error
|
| Suzhou AcuVu Medical Technology FDA
EU representative : Eunitor GmbH (Germany)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Suzhou Sunland Medical
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
I
MDR
|
EUDAMED record
Report an error
|
| Taktvoll FDA
EU representative : MedPath GmbH (Germany)
|
China
|
|
I
MDR
|
Website
EUDAMED record
Report an error
|
| Transmed FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
IIa
MDR
|
sales@transmed.com.cn
EUDAMED record
Report an error
|
| Yigaomedical FDA
EU representative : TRANSMED GLOBAL CONSULTING, S.L. (Spain)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Zhejiang Tiansong Medical Instrument FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Zsrbiomedical FDA
EU representative : Caretechion GmbH (Germany)
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|
| Zumax Medical FDA
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
I
MDR
|
sales@zumaxmedical.com
EUDAMED record
Report an error
|
| Henan Tuoren Kingtaek Medical Device
EU representative : MedNet EC-REP GmbH (Germany)
No model still on the market
|
China
|
|
IIa
MDR
|
EUDAMED record
Report an error
|