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Results for “enVast”

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Registry EUDAMED 49 FDA 510(k) FDA PMA GUDID 4

Country / market European Union (all) 49 United States 4

More countries (3)

Ireland 45 Germany 3 Belgium 1

Risk class Class I Class IIa 45 Class IIb Class III 4 Class II (US) 4

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) Not classified (FDA)

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53 devices foundsorted by relevance

Device · Manufacturer · Authorizations

Tahina 0.038" Ureteral Balloon Dilator UDI-DI 60913190404300

Envaste Ltd,Mauritius Class IIa

Active CE MDR EUDAMED IIa
11 variants
- Tahina 0.038" Ureteral Balloon Dilator UDB-0105100S
- Tahina 0.038" Ureteral Balloon Dilator UDB-0106040S
- Tahina 0.038" Ureteral Balloon Dilator UDB-0106100S
- See all variants of this device
Manawa Access Sheath UDI-DI 60913190403860

Envaste Ltd,Mauritius Class IIa

Active CE MDR EUDAMED IIa
16 variants
- Manawa Access Sheath UAS-0110728S
- Manawa Access Sheath UAS-0110735S
- Manawa Access Sheath UAS-0114045S
- See all variants of this device
Amara Balloon Dilator UDI-DI 60913190402184

Envaste Ltd,Mauritius Class IIa

Active CE MDR EUDAMED IIa
14 variants
- Amara Balloon Dilator GDB-0111555S
- Amara Balloon Dilator GDB-0111855S
- Amara Balloon Dilator GDB-0120655S
- Amara Balloon Dilator GDB-0121855S
- See all variants of this device

Showing 41-53 of 53

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