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Registry EUDAMED 1,264 FDA 510(k) 13 FDA PMA GUDID 63

Country / market European Union (all) 1,261 United States 76

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France 1,224 Italy 27 Denmark 9 Türkiye 2 Netherlands 1 Northern Ireland 1

Risk class Class I 7 Class IIa 6 Class IIb 1,244 Class III Class II (US) 71

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Class A 1 Class B Class C Class D IVD General 9 IVD Annex II List A IVD Annex II List B 1 IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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Synthesis UDI-DI 03760284922456

Cutting Edge SAS,France

Active Regimes: CE MDD Registry: EUDAMED Class:IIb
1,000+ variants
- Synthesis PPLUS+15.25D
- Synthesis PPLUST075+10.00
- Synthesis PPLUST150+20.00
- Synthesis PPLUST300+14.50
- Synthesis PPLUST300+21.00
- Synthesis PPLUST450+27.00
- Synthesis PPLUST525+13.00
- Synthesis PPLUST525+15.00
- Synthesis PPLUST525+20.00
- Synthesis PPLUST600+13.50
- Synthesis PYPLUS+29.25D
- Synthesis SIP+15.50D
- Synthesis SIP+37.00D
- Synthesis SIPT075+26.50
- Synthesis SIPT225+08.00
- Synthesis SIPT300+12.00
- See all variants of this device

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