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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

Device · Manufacturer · Authorizations

Falcon 2.0 UDI-DI 05908015741732

EnSafe sp.z o.o.,Poland Class I

Active CE MDR EUDAMED I
132 variants
- Falcon 2.0 K.F2.014
- Falcon 2.0 K.F2.020
- Falcon 2.0 K.F2.025
- Falcon 2.0 K.F2.027
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Everest 2.0 UDI-DI 05908015740681

EnSafe sp.z o.o.,Poland Class I

Active CE MDR EUDAMED I
129 variants
- Everest 2.0 K.E2.000
- Everest 2.0 K.E2.018
- Everest 2.0 K.E2.044
- Everest 2.0 K.E2.060
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Comfort UDI-DI 05908015742982

EnSafe sp.z o.o.,Poland Class I

Active CE MDR EUDAMED I
4 variants
- Comfort PR.CO.000
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Reptor UDI-DI 05908015742920

EnSafe sp.z o.o.,Poland Class I

Active CE MDR EUDAMED I
6 variants
- Reptor K.RE.001
- Reptor K.RE.006
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Robin 2.0 UDI-DI 05908015741374

EnSafe sp.z o.o.,Poland Class I

Active CE MDR EUDAMED I
119 variants
- Robin 2.0 K.R2.009
- Robin 2.0 K.R2.025
- Robin 2.0 K.R2.052
- Robin 2.0 K.R2.061
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Showing 21-40 of 406

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