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Results for “Biogel Surgeons”

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Registry EUDAMED 32 FDA 510(k) 1 FDA PMA GUDID 8

Country / market European Union (all) 24 United States 9

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Sweden 24

Risk class Class I 9 Class IIa 24 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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33 devices foundsorted by relevance

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Biogel Surgeons UDI-DI 05060097931170

Mölnlycke Health Care AB,Sweden Class IIa

Active CE MDR EUDAMED IIa
16 variants
- Biogel Surgeons 82255
- Biogel Surgeons 82265
- Biogel Surgeons 82275
- Biogel Surgeons 82290
- Biogel Surgeons 96160
- Biogel Surgeons 96165
- Biogel Surgeons 96180
- Biogel Surgeons 96190
- See all variants of this device
Biogel Pack Surgeons UDI-DI 07333350148829

Mölnlycke Health Care AB,Sweden Class IIa

Active CE MDR EUDAMED IIa
8 variants
- Biogel Pack Surgeons 1182280
- Biogel Pack Surgeons 1182290
- See all variants of this device
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim

Molnlycke Health Care Us, LLC,United States(FDA 510(k) applicant) Class I

Active 510(k) 510(k) I

Showing 21-33 of 33

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