Fysicon B.V.

SRN: NL-MF-000002694 · Hoogheuvelstraat 114, 5349 BA Oss, Netherlands

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Hoogheuvelstraat 114, 5349 BA Oss, Netherlands
Email: [email protected]
Phone: +31 412 65 33 33
Website: www.fysicon.com

Regulatory Overview

Regulation

Eu Mdr 4

Classification

Eu Md Class 1 3

Eu Md Class 2b 1

Device Types

Certificate Health

Total

Valid

Expiring < 6mo

Expired / Withdrawn

Certificates by Expiry Year

Type	Number	Notified Body	Legislation	Issue Date	Expiry Date	Status
MDR QMS	21M00066CRT02	Kiwa Dare B.V.	MDR	Oct 2024	Mar 14, 2025	Amended

Market Presence

Devices from this manufacturer are available in 31 countries across Europe.

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

Device Portfolio

Name	Regulation	Classification	Market Status
Leadset (10 pcs) IEC, Grabber, Radiopaque (4 Limb 130cm - 6 Chest 70cm)	EU MDR	Eu Md Class 1	On Market
01853004 Reusable NiBP Cuff, Adult (Grey), 23-33 cm (01)08719689142490	EU MDR	Eu Md Class 1	On Market
01853006 Reusable NiBP Cuff, Large Adult (Burgundy), 31-40 cm (01)08719689142513	EU MDR	Eu Md Class 1	On Market
01853008 Reusable NiBP Cuff, Thigh (Brown), 38-50 cm (01)08719689142537	EU MDR	Eu Md Class 1	On Market
10 Lead (AHA) radiopaque lead wire set with grabber	EU MDR	Eu Md Class 1	On Market
5 Lead (IEC) Radiopaque Lead wire set with grabber 5x130 CM	EU MDR	Eu Md Class 1	On Market
5 Lead (IEC) Radiopaque Lead wire set with snap 5x70 CM	EU MDR	Eu Md Class 1	On Market
DataLinQ CRM	EU MDR	Eu Md Class 1	On Market
DataLinQ RDM Cloud	EU MDR	Eu Md Class 1	On Market
DataLinQ USG	EU MDR	Eu Md Class 1	On Market
DataLinQ2PAD	EU MDR	Eu Md Class 1	On Market
Disposable NiBP Cuff, Neonate (Burgundy), 8-15 cm, Box 20 pcs	EU MDR	Eu Md Class 1	On Market
Disposable NiBP Cuff, Neonate (Green), 6-11 cm, Box 20 pcs	EU MDR	Eu Md Class 1	On Market
Disposable NiBP Cuff, Neonate (Navy Blue), 7-13 cm, Box 20 pcs	EU MDR	Eu Md Class 1	On Market
Disposable NiBP Cuff, Neonate (Orange), 3-6 cm, Box 20 pcs	EU MDR	Eu Md Class 1	On Market
Disposable NiBP Cuff, Neonate (Turquoise), 4-8 cm, Box 20 pcs	EU MDR	Eu Md Class 1	On Market
EVOCS	EU MDR	Eu Md Class 1	On Market
IBP Cable Medex Logical – CR Bard, Boston Scientific (320CM)	EU MDR	Eu Md Class 1	On Market
IBP Cable Medex Logical – David/Metek (320CM)	EU MDR	Eu Md Class 1	On Market
IBP Cable Medex Logical – Marquette 7000 (320CM)	EU MDR	Eu Md Class 1	On Market
IBP Cable Medex Logical – Prucka (320CM)	EU MDR	Eu Md Class 1	On Market
IBP Cable Medex Logical – Siemens 7p (320CM)	EU MDR	Eu Md Class 1	On Market
IBP cable I-connect-MedEx	EU MDR	Eu Md Class 1	On Market
QMAPP 10 Lead ECG Trunk cable, AHA, 320 CM	EU MDR	Eu Md Class 1	On Market
QMAPP 10 Lead ECG Trunk cable, IEC 320 CM	EU MDR	Eu Md Class 1	On Market
QMAPP 10 Lead ECG trunk cable, IEC 165 cm	EU MDR	Eu Md Class 1	On Market
QMAPP 10Lead ECG trunk cable AHA, 165 cm	EU MDR	Eu Md Class 1	On Market
QMAPP 5 Lead (AHA) Radiopaque Lead wire set with grabber, 5x70 CM	EU MDR	Eu Md Class 1	On Market
QMAPP 5 Lead (AHA) Radiopaque Lead wire set with snap, 5x70 CM	EU MDR	Eu Md Class 1	On Market
QMAPP 5 Lead ECG Trunk cable, AHA 320 CM	EU MDR	Eu Md Class 1	On Market
QMAPP 5 Lead ECG Trunk cable, IEC 165 CM	EU MDR	Eu Md Class 1	On Market
QMAPP 5 Lead ECG Trunk cable, IEC 320 CM	EU MDR	Eu Md Class 1	On Market
QMAPP AUX cable to 6.3 mm Mono Jack for Volcano i5, Black 165 CM	EU MDR	Eu Md Class 1	On Market
QMAPP AUX cable to bipolar touch-protected 2mm inline socket 3 M	EU MDR	Eu Md Class 1	On Market
QMAPP AUX to BNC cable	EU MDR	Eu Md Class 1	On Market
QMAPP Dual 'Y' - Temperature connection cable	EU MDR	Eu Md Class 1	On Market
QMAPP Dual `Y`- IBP Connection cable	EU MDR	Eu Md Class 1	On Market
QMAPP FFR Connection cable - Abbott (SJM) Pressure wire receiver 320 CM	EU MDR	Eu Md Class 1	On Market
QMAPP FFR Connection cable - Abbott (SJM) Pressure wire receiver 65 CM	EU MDR	Eu Md Class 1	On Market
QMAPP FFR Connection cable - Abbott (SJM) Wibox 320 CM	EU MDR	Eu Md Class 1	On Market
QMAPP FFR Connection cable - Boston FFR Link, Pa 320 CM	EU MDR	Eu Md Class 1	On Market
QMAPP FFR Connection cable - Boston FFR Link, Pd 320 CM	EU MDR	Eu Md Class 1	On Market
QMAPP FFR Connection cable - Volcano (Philips) SmartMap 320 CM	EU MDR	Eu Md Class 1	On Market
QMAPP GO	EU MDR	Eu Md Class 2b	On Market
QMAPP HEMO	EU MDR	Eu Md Class 2b	On Market
QMAPP HEMO LT	EU MDR	Eu Md Class 2b	On Market
QMAPP IBP Connection cable - Abbott 320 CM	EU MDR	Eu Md Class 1	On Market
QMAPP IBP Connection cable - Edwards, Baxter 320 cm	EU MDR	Eu Md Class 1	On Market
QMAPP IBP Connection cable - Medex Logcal 320 CM	EU MDR	Eu Md Class 1	On Market
QMAPP IBP Connection cable - Merit 320 CM	EU MDR	Eu Md Class 1	On Market

View all 76 devices →

PRRC #1

Name

Patricia Steenstra

Country

🇳🇱 Netherlands

PRRC #2

Name

Eric van Antwerpen

Country

🇳🇱 Netherlands

Notified Bodies

Kiwa Dare B.V.

1 cert

Competent Authority

Name

Ministry of Health, Welfare and Sports

Country

🇳🇱 Netherlands

More about this competent authority →

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