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Registry EUDAMED ~384 FDA 510(k) ~16 FDA PMA GUDID

Country / market European Union (all) ~384 United States ~16

More countries (6)

Germany ~361 Italy ~12 France ~7 Portugal ~2 Austria ~1 Spain ~1

Risk class Class I ~30 Class IIa ~357 Class IIb Class III Class II (US) ~11

More classes (11)

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) ~1 Not classified (FDA)

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NeoDiamond UDI-DI 00840221637551

Microcopy, A Division of Neo-Flo, Inc.,United States Class IIa

Active CE MDR EUDAMED IIa
1,000+ variants
- NeoDiamond 111-010C
- NeoDiamond 166-024SC
- NeoDiamond 169-010M
- NeoDiamond 173-014F
- NeoDiamond 199-016SHXC
- NeoDiamond 249-016XF
- NeoDiamond 257-023XXC
- NeoDiamond 297-016XC
- NeoDiamond 299-012SXC
- NeoDiamond 546-016F
- NeoDiamond 546-020SXC
- NeoDiamond HP 001024C
- NeoDiamond HR250-012SXC
- NeoDiamond R04 360 504 190
- NeoDiamond RA199-014F
- NeoDiamond S04 332 514 220
- See all variants of this device
NeoBurr UDI-DI 00840221632792

Microcopy, A Division of Neo-Flo, Inc.,United States Class IIa

Active CE MDR EUDAMED IIa
196 variants
- See all variants of this device
NeoShine UDI-DI 00818963024151

Microcopy, A Division of Neo-Flo, Inc.,United States Class IIa

Active CE MDR EUDAMED IIa
19 variants
- See all variants of this device

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