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Results for “Bio-Pen”

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Registry EUDAMED 327 FDA 510(k) incl. De Novo 34 FDA PMA GUDID 56

Country / market European Union (all) 309 United States 90

More countries (14)

Austria 202 Greece 38 Germany 23 Poland 16 Estonia 13 Türkiye 10 Netherlands 6 Spain 3 Hungary 3 Malta 2 France 1 Italy 1 Romania 1 Northern Ireland 1

Risk class Class I 30 Class IIa 260 Class IIb 34 Class III 2 Class II (US) 67

More classes (11)

Class A Class B 4 Class C Class D IVD General 19 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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416 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

Disposable Biopsy Forceps

Zhuji Pengtian Medical Instrument Co., Ltd.,China Group of variants

Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa
Maxima

Bio-Med Healthcare Products Pvt. Ltd.,India Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Bio-Flon

Bio-Med Healthcare Products Pvt. Ltd.,India

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Bio-Pen

Bio-Med Healthcare Products Pvt. Ltd.,India

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Neo-Kath

Bio-Med Healthcare Products Pvt. Ltd.,India

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Biolan®

Penta Arzneimittel GmbH,Germany

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
Bio-On

Bio-Med Healthcare Products Pvt. Ltd.,India Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Bio-Can

Bio-Med Healthcare Products Pvt. Ltd.,India

Active Regimes: CE MDR Registry: EUDAMED Class:IIa

Showing 81-100 of 416

deviCERTS Global Medical Device Regulatory Database

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