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Registry EUDAMED ~400 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) ~400

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France ~224 Germany ~85 Czechia ~70 Belgium ~21

Risk class Class I Class IIa Class IIb ~400 Class III Class II (US)

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

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Manufacturer: Cutting Edge SAS× Clear all

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Synthesis UDI-DI 03665493020408

Cutting Edge SAS,France Class IIb

Active CE MDD EUDAMED IIb
1,000+ variants
- Synthesis PPLUS+23.00D
- Synthesis PPLUST075+16.00
- Synthesis PPLUST075+26.00
- Synthesis PPLUST100+18.00
- Synthesis PPLUST100+26.50
- Synthesis PPLUST525+23.00
- Synthesis PYPLUS+13.75D
- Synthesis SIPT225+11.00
- Synthesis SIPT300+29.00
- Synthesis SIPT375+21.00
- Synthesis SIPT375+25.00
- Synthesis SIPT375+31.00
- Synthesis SIPY+23.50D
- Synthesis SIPY+29.00D
- Synthesis SIPY+31.00D
- See all variants of this device
Luxsmart UDI-DI 03665493045777

Cutting Edge SAS,France Class IIb

Active CE MDD EUDAMED IIb
559 variants
- Luxsmart YSMARTT075+245
- See all variants of this device
Luxgood UDI-DI 03665493033446

Cutting Edge SAS,France Class IIb

Active CE MDD EUDAMED IIb
559 variants
- Luxgood YGOODT525+155
- See all variants of this device

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