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Results for “Bunion Night Splint”

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Registry EUDAMED 23 FDA 510(k) incl. De Novo FDA PMA GUDID 1

Country / market European Union (all) 23 United States 1

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Germany 8 Ireland 7 Italy 4 Austria 3 Slovenia 1

Risk class Class I 24 Class IIa Class IIb Class III Class II (US)

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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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24 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

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Registry

Class

Bunion Night Splint

Orthotech Rehabilitation Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
Hinged Bunion Night Splint

e-life International Co., Ltd.,Taiwan

Active Regimes: CE MDR Registry: EUDAMED Class:I
Bunion Night Splint

Zhangpu Ortholife Rehabilitation Co., Ltd.,China

Active Regimes: CE MDR Registry: EUDAMED Class:I

Showing 21-24 of 24

deviCERTS Global Medical Device Regulatory Database

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