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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

Robin 2.0 UDI-DI 05906112206086

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

Active CE MDR EUDAMED I
119 variants
- Robin 2.0 K.R2.032
- Robin 2.0 K.R2.038
- Robin 2.0 K.R2.057
- Robin 2.0 K.R2.087
- Robin 2.0 K.R2.102
- See all variants of this device
Everest 2.0 UDI-DI 05908015740704

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

Active CE MDR EUDAMED I
129 variants
- Everest 2.0 K.E2.025
- Everest 2.0 K.E2.026
- Everest 2.0 K.E2.046
- Everest 2.0 K.E2.104
- See all variants of this device
Falcon 2.0 UDI-DI 05908015741879

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

Active CE MDR EUDAMED I
132 variants
- Falcon 2.0 K.F2.048
- Falcon 2.0 K.F2.064
- Falcon 2.0 K.F2.075
- Falcon 2.0 K.F2.102
- Falcon 2.0 K.F2.115
- Falcon 2.0 K.F2.120
- See all variants of this device
Reptor UDI-DI 05908015742913

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

Active CE MDR EUDAMED I
6 variants
- See all variants of this device
Prime UDI-DI 05908015740995

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

Active CE MDR EUDAMED I
2 variants
- See all variants of this device

Showing 141-160 of 406

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