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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 00840221600951

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

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
1,000+ variants
- NeoDiamond 002-017C
- NeoDiamond 010-012SC
- NeoDiamond 010-014F
- NeoDiamond 109-011SC
- NeoDiamond 109-011SM
- NeoDiamond 130-016C
- NeoDiamond 173-016C
- NeoDiamond 173-021SXC
- NeoDiamond 198-017XC
- NeoDiamond 199-016XF
- NeoDiamond 233-016F
- NeoDiamond 249-016SM
- NeoDiamond 250-012SXC
- NeoDiamond 298-012SM
- NeoDiamond 342 514 190
- NeoDiamond HP 490115XXC
- See all variants of this device
NeoBurr UDI-DI 00840221632075

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

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
196 variants
- See all variants of this device

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