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Registry EUDAMED ~399 FDA 510(k) ~1 FDA PMA GUDID

Country / market European Union (all) ~387 United States ~1

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Italy ~332 Austria ~25 Netherlands ~20 Germany ~6 Türkiye ~4 Greece ~3 France ~1

Risk class Class I ~25 Class IIa ~15 Class IIb ~41 Class III Class II (US) ~1

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Class A ~189 Class B Class C ~3 Class D IVD General ~126 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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Manufacturer: Biotec S.R.L.× Clear all

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Cutter stop, cutter stop ring, 3D assembly devices spacer UDI-DI +D748528NA50805

Biotec S.R.L.,Italy Class I

Active CE MDR EUDAMED I
115 variants
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Surgical instruments UDI-DI +D748443HR22003

Biotec S.R.L.,Italy Class IIa

Active CE MDR EUDAMED IIa
496 variants
- Surgical instruments 433HS340
- Surgical instruments 445HR602
- Surgical instruments 451HR313
- Surgical instruments 470HR330
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Abutment UDI-DI +D748210ER2A000

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
448 variants
- Abutment 220ER2F0
- Abutment 220KR3E1
- Abutment 262KR3A0
- Abutment 265KT3R0
- Abutment 266EN2L0
- Abutment MMP36N13
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CAD-CAM Base UDI-DI +D748246IV1A10H

Biotec S.R.L.,Italy Class IIb

Active CE MDR EUDAMED IIb
316 variants
- CAD-CAM Base 246IU1A0
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Single-use sampling device UDI-DI 06980361381076

Shandong Chengwu Ronghua Biotechnology Co., Ltd.,China Class I

Active CE MDR EUDAMED I
2 variants
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Scan Abutment UDI-DI +D748352IS1A00B

Biotec S.R.L.,Italy Class IIa

Active CE MDR EUDAMED IIa
61 variants
- Scan Abutment 352EW1A0
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Impression Post UDI-DI +D748325ER0A005

Biotec S.R.L.,Italy Class IIa

Active CE MDR EUDAMED IIa
113 variants
- Impression Post ATO60MN0
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