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Registry EUDAMED 259 FDA 510(k) 4 FDA PMA GUDID

Country / market European Union (all) 259 United States 4

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Germany 259

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

More classes (11)

Class A Class B Class C Class D IVD General 259 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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263 devices foundsorted by relevance

Manufacturer: Innovacon, Inc.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

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SureStep CE UDI-DI 00815845024131

Innovacon, Inc.,United States

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
212 variants
- SureStep CE DBA-167-026
- SureStep CE DBE-187-191
- SureStep CE DBO-177-241
- SureStep CE DBZ-114
- SureStep CE DFT-101
- SureStep CE DOA-134-101
- SureStep CE DOA-134-141
- SureStep CE DOA-144-841
- SureStep CE DOA-154-1191
- SureStep CE DOA-154-1451
- SureStep CE DOA-154-1661
- SureStep CE DOA-164-041
- SureStep CE DOA-164-2031
- SureStep CE DOA-165-061
- SureStep CE DOA-165-071
- SureStep CE DUD-1104-1291
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SureStep UDI-DI 00815845022687

Innovacon, Inc.,United States

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
20 variants
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Strep A Rapid Test (Throat Swab) UDI-DI 00810124272777

Innovacon, Inc.,United States

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
5 variants
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Showing 121-140 of 263

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