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Registry EUDAMED ~1,976 FDA 510(k) ~6 FDA PMA GUDID ~233

Country / market European Union (all) ~1,624 United States ~238

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Hungary ~1,216 France ~236 Türkiye ~206 Germany ~83 Belgium ~23 Netherlands ~20 Austria ~15 Poland ~9 Sweden ~6 Czechia ~4 Spain ~3 Ireland ~3 Italy ~3 Norway ~3 Portugal ~3

Risk class Class I ~487 Class IIa ~1,139 Class IIb ~284 Class III ~48 Class II (US) ~39

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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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TraumaCad Neo (1.1)

Brainlab Ltd,Israel Class II

Active CE MDR 510(k) EUDAMED510(k)GUDID II
Materialise Mimics Enlight CMF Orthognathic and Trauma Planner

Materialise NV,Belgium Class II

Active CE MDR EUDAMEDGUDID II
Instruments for trauma and orthopaedic surgery UDI-DI 03700569627362

Newclip Technics SAS,France Class I

Active CE MDR EUDAMEDGUDID I
95 variants
- Instruments for trauma and orthopaedic surgery ANC314
- Instruments for trauma and orthopaedic surgery ANC427
- Instruments for trauma and orthopaedic surgery ANC998
- Instruments for trauma and orthopaedic surgery ANC1368
- Instruments for trauma and orthopaedic surgery ANC1513
- Instruments for trauma and orthopaedic surgery ANC1542
- Instruments for trauma and orthopaedic surgery ANC1559
- Instruments for trauma and orthopaedic surgery ANC1579
- Instruments for trauma and orthopaedic surgery ANC1597
- Instruments for trauma and orthopaedic surgery ANC1602
- Instruments for trauma and orthopaedic surgery ANC1610
- Instruments for trauma and orthopaedic surgery ANC1628
- Instruments for trauma and orthopaedic surgery ANC1853
- Instruments for trauma and orthopaedic surgery ANC1860
- Instruments for trauma and orthopaedic surgery ANC1888
- See all variants of this device
Instruments for trauma and orthopaedic surgery UDI-DI 03700569634872

Newclip Technics SAS,France Class IIa

Active CE MDR EUDAMEDGUDID IIa
38 variants
- Instruments for trauma and orthopaedic surgery ANC1288
- See all variants of this device

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