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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 00840221601545

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

Active CE MDR EUDAMED IIa
1,000+ variants
- NeoDiamond 001-021XC
- NeoDiamond 002-012M
- NeoDiamond 010-016C
- NeoDiamond 141-012XF
- NeoDiamond 164-014C
- NeoDiamond 166-014SUF
- NeoDiamond 298-014SC
- NeoDiamond 299-019SF
- NeoDiamond 546-016C
- NeoDiamond 552-021M
- NeoDiamond G/111-014M
- NeoDiamond G/166-017M
- NeoDiamond H298-018XC
- NeoDiamond HP 490090
- NeoDiamond R04 340 514 100
- NeoDiamond S04 345 494 220
- See all variants of this device
NeoDiamond UDI-DI 00840221637841

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

Active CE MDR EUDAMED I
24 variants
- See all variants of this device
NeoBurr UDI-DI 00840221631528

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

Active CE MDR EUDAMED IIa
196 variants
- NeoBurr FG.TC 161
- See all variants of this device

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