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Registry EUDAMED 19 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) 1

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Northern Ireland 18 Ireland 1

Risk class Class I 19 Class IIa Class IIb 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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19 devices foundsorted by relevance

Manufacturer: Talarmade× Clear all

Device · Manufacturer · Authorizations

KinetiX UDI-DI 05055204343939

Talarmade,United Kingdom Class I

Active CE MDR EUDAMED I
6 variants
- KinetiX KA1030
- KinetiX KA1050
- KinetiX KA1130
- KinetiX KA1150
- KinetiX KA1230
DiabetiX Insole - EU34 UDI-DI 50552043473266

Talarmade,United Kingdom Class I

Active CE MDR EUDAMED I
9 variants
- DiabetiX Insole - EU34 TM-DX/EU34/PR
- DiabetiX Insole - EU34 TM-DX/EU36/PR
- DiabetiX Insole - EU34 TM-DX/EU40/PR
- DiabetiX Insole - EU34 TM-DX/EU42/PR
- DiabetiX Insole - EU34 TM-DX/EU44/PR
- DiabetiX Insole - EU34 TM-DX/EU46/PR
- DiabetiX Insole - EU34 TM-DX/EU48/PR
- DiabetiX Insole - EU34 TM-DX/EU50/PR
Pressure Relief AFO UDI-DI 50552043066376

Talarmade,United Kingdom Class I

Active CE MDR EUDAMED I
3 variants
- Pressure Relief AFO APRB/L
- Pressure Relief AFO AUPRNS
HeadUp Collar

Talarmade,United Kingdom Class I

Active CE MDR EUDAMED I

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