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Registry EUDAMED 10 FDA 510(k) 1 FDA PMA GUDID

Country / market European Union (all) 10 United States 1

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Germany 10

Risk class Class I 2 Class IIa Class IIb Class III 8 Class II (US) 1

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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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11 devices foundsorted by relevance

Manufacturer: CathRx, Ltd.× Clear all

Device · Manufacturer · Authorizations

Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters

CathRx, Ltd.,Australia Class II

Active CE MDD 510(k) EUDAMED510(k) II
Khelix Diagnostic Extension Cable 10pin

CathRx, Ltd.,Australia Class I

Active CE MDD EUDAMED I
Khelix Duodecapolar Variable Loop Steerable Electrophysiology Catheter

CathRx, Ltd.,Australia Class III

Active CE MDD EUDAMED III
Khelix Quadpolar Fixed Electrophysiology Catheter

CathRx, Ltd.,Australia Class III

Active CE MDD EUDAMED III
Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter UDI-DI 09351351000074

CathRx, Ltd.,Australia Class III

Active CE MDD EUDAMED III
2 variants
- Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter SC1-B20U-10P7666
Khelix Diagnostic Extension Cable 20pin

CathRx, Ltd.,Australia Class I

Active CE MDD EUDAMED I
Khelix Decapolar Steerable Electrophysiology Catheter UDI-DI 09351351000050

CathRx, Ltd.,Australia Class III

Active CE MDD EUDAMED III
3 variants
- Khelix Decapolar Steerable Electrophysiology Catheter SS1-D0U-10A6252
- Khelix Decapolar Steerable Electrophysiology Catheter SS1-G0U-10A6252
Khelix Duodecapolar Steerable Electrophysiology Catheter

CathRx, Ltd.,Australia Class III

Active CE MDD EUDAMED III

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