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Registry EUDAMED ~2,000 FDA 510(k) FDA PMA GUDID ~345

Country / market European Union (all) ~1,418 United States ~345

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Poland ~995 Belgium ~321 Germany ~75 Italy ~27

Risk class Class I ~11 Class IIa Class IIb ~1,974 Class III Class II (US) ~15

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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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Viper System UDI-DI 10705034351629

Medos International SARL,Switzerland Class IIb

Active CE MDR EUDAMEDGUDID IIb
210 variants
- Viper System 179704870
- Viper System 179704990
- Viper System 179706170
- Viper System 186715425
- Viper System 186715435
- Viper System 186715730
- Viper System 186719780
- Viper System 186727945
- Viper System 186731530
- Viper System 186731835
- See all variants of this device
Viper Prime UDI-DI 10705034509365

Medos International SARL,Switzerland Class IIb

Active CE MDR EUDAMEDGUDID IIb
107 variants
- Viper Prime 186745255
- Viper Prime 186745435
- Viper Prime 186750445S
- Viper Prime 186760235
- Viper Prime 186760255
- Viper Prime 186770355
- Viper Prime 186775235
- Viper Prime 186775255
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