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Registry EUDAMED ~400 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) ~337

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Netherlands ~284 Belgium ~53

Risk class Class I ~27 Class IIa ~96 Class IIb ~176 Class III ~101 Class II (US)

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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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Armada™ 18 PTA Catheter UDI-DI 08717648211393

Abbott Medical,Ireland Class IIa

Active CE MDR EUDAMED IIa
126 variants
- Armada™ 18 PTA Catheter 1014255-180
- Armada™ 18 PTA Catheter 1014259-100
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Absolute Pro™ Peripheral Self-Expanding Stent System UDI-DI 08717648114823

Abbott Medical,Ireland Class IIb

Expiring CE MDR EUDAMED IIb
144 variants
- Absolute Pro™ Peripheral Self-Expanding Stent System 1011921-060
- Absolute Pro™ Peripheral Self-Expanding Stent System 1011922-040
- Absolute Pro™ Peripheral Self-Expanding Stent System 1012832-100
- Absolute Pro™ Peripheral Self-Expanding Stent System 1012834-30
- Absolute Pro™ Peripheral Self-Expanding Stent System 1012835-100
- Absolute Pro™ Peripheral Self-Expanding Stent System 1012837-60
- Absolute Pro™ Peripheral Self-Expanding Stent System 1012843-80
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Omnilink Elite™ Peripheral Stent System UDI-DI 08717648128103

Abbott Medical,Ireland Class IIb

Expiring CE MDR EUDAMED IIb
64 variants
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RX Herculink Elite™ Peripheral Stent System UDI-DI 08717648084782

Abbott Medical,Ireland Class IIb

Expiring CE MDR EUDAMED IIb
40 variants
- RX Herculink Elite™ Peripheral Stent System 1011524-15
- RX Herculink Elite™ Peripheral Stent System 1011537-12
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Esprit™ BTK Everolimus Eluting Resorbable Scaffold System UDI-DI 08717648364754

Abbott Medical,Ireland Class III

Active CE MDR EUDAMED III
128 variants
Absolute Pro™ LL Peripheral Self-Expanding Stent System UDI-DI 08717648191572

Abbott Medical,Ireland Class IIb

Expiring CE MDR EUDAMED IIb
32 variants
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Hi-Torque Command™ Guide Wire with Hydrophilic Coating

Abbott Medical,Ireland Class IIa

Active CE MDR EUDAMED IIa

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