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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 05908015741565

EnSafe Sp. z o.o.,Poland

Active Regimes: CE MDR Registry: EUDAMED Class:I
132 variants
- Falcon 2.0 K.F2.018
- Falcon 2.0 K.F2.026
- Falcon 2.0 K.F2.031
- Falcon 2.0 K.F2.033
- Falcon 2.0 K.F2.041
- Falcon 2.0 K.F2.077
- Falcon 2.0 K.F2.090
- Falcon 2.0 K.F2.117
- Falcon 2.0 K.F2.130
- See all variants of this device
Robin 2.0 UDI-DI 05906112206390

EnSafe Sp. z o.o.,Poland

Active Regimes: CE MDR Registry: EUDAMED Class:I
119 variants
- Robin 2.0 K.R2.004
- Robin 2.0 K.R2.042
- Robin 2.0 K.R2.060
- See all variants of this device
Everest 2.0 UDI-DI 05908015740537

EnSafe Sp. z o.o.,Poland

Active Regimes: CE MDR Registry: EUDAMED Class:I
129 variants
- Everest 2.0 K.E2.013
- Everest 2.0 K.E2.024
- Everest 2.0 K.E2.049
- Everest 2.0 K.E2.052
- Everest 2.0 K.E2.090
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Showing 301-320 of 406

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