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

Country / market European Union (all) ~400

More countries (4)

Poland ~387 Austria ~9 Finland ~3 Bulgaria ~1

Risk class Class I ~400 Class IIa Class IIb Class III Class II (US)

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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406 devices foundsorted by relevance

Manufacturer: EnSafe sp.z o.o.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

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Falcon 2.0 UDI-DI 05908015740308

EnSafe Sp. z o.o.,Poland

Active Regimes: CE MDR Registry: EUDAMED Class:I
132 variants
- Falcon 2.0 K.F2.011
- Falcon 2.0 K.F2.015
- Falcon 2.0 K.F2.024
- Falcon 2.0 K.F2.036
- Falcon 2.0 K.F2.079
- Falcon 2.0 K.F2.098
- Falcon 2.0 K.F2.109
- Falcon 2.0 K.F2.128
- See all variants of this device
Robin 2.0 UDI-DI 05908015743095

EnSafe Sp. z o.o.,Poland

Active Regimes: CE MDR Registry: EUDAMED Class:I
119 variants
- Robin 2.0 K.R2.074
- Robin 2.0 K.R2.084
- Robin 2.0 K.R2.085
- Robin 2.0 K.R2.086
- Robin 2.0 K.R2.089
- Robin 2.0 K.R2.093
- Robin 2.0 K.R2.103
- Robin 2.0 K.R2.108
- Robin 2.0 K.R2.109
- Robin 2.0 K.R2.111
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Showing 281-300 of 406

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