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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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Luxgood UDI-DI 03665493027742

Cutting Edge SAS,France Class IIb

Active CE MDD EUDAMED IIb
559 variants
- Luxgood GOOD+13.00D
- Luxgood YGOODT525+100
- Luxgood YGOODT600+295
- See all variants of this device
Synthesis UDI-DI 03760284921114

Cutting Edge SAS,France Class IIb

Active CE MDD EUDAMED IIb
1,000+ variants
- Synthesis PPLUS+26.00D
- Synthesis PPLUS+31.00D
- Synthesis PPLUST450+15.00
- Synthesis PPLUST600+17.50
- Synthesis PPLUST600+27.50
- Synthesis PYPLUS+25.75D
- Synthesis SIPT225+19.00
- Synthesis SIPT225+30.00
- Synthesis SIPT300+15.00
- Synthesis SIPT300+18.50
- Synthesis SIPT525+08.00
- Synthesis SIPT525+17.50
- Synthesis SIPT600+12.00
- Synthesis SIPY+19.00D
- See all variants of this device
Luxsmart UDI-DI 03665493045241

Cutting Edge SAS,France Class IIb

Active CE MDD EUDAMED IIb
559 variants
- See all variants of this device

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