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Registry EUDAMED 15 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 15

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Spain 15

Risk class Class I Class IIa 1 Class IIb Class III 14 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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15 devices foundsorted by relevance

Manufacturer: Galaxy Therapeutics, Inc.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

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SEAL™ Detachment Handle

Galaxy Therapeutics, Inc.,United States

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Seal™ Arc

Galaxy Therapeutics, Inc.,United States Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:III
SEAL™ Base

Galaxy Therapeutics, Inc.,United States Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:III

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deviCERTS Global Medical Device Regulatory Database

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