Notified Body
NB 1912
🇳🇱 Netherlands
Kiwa Dare B.V.
Vijzelmolenlaan 7, NL-3447 GX Woerden, Netherlands
View on EUDAMED
Updated Apr 8, 2023
Certificates
36
Valid
22
Expiring < 6mo
0
Expired
13
Basic UDI-DIs
4
Devices
4
Manufacturers
32
Cert. Types
3
Basic Information
- Address
- Vijzelmolenlaan 7, NL-3447 GX Woerden, Netherlands
- [email protected]
- Phone
- +31 348 200 900
- Website
- www.dare.nl
Regulatory Overview
Regulation
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Eu Mdd
4
Classification
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Eu Md Class 2a
3
Eu Md Class 3
1
Device Types
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Certificate Health
Total
36
Valid
22
Expiring < 6mo
0
Expired / Withdrawn
14
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 456 | Inion Oy | Apr 24, 2023 | |||
| MDR QMS | 20M00066CRT04 | Intelligent Ultrasound Limited | MDR | Apr 2021 | Apr 08, 2024 | Issued |
| MDD Annex II (excluding section 4) | 20M00105CRT01 | NICo-Lab B.V. | May 26, 2024 | |||
| MDD Annex IV | 19M00096CRT02 | RELEGS BV | May 27, 2024 | |||
| MDR QMS | 19M00166CRT04 | Dear Health Holding Company B.V. | MDR | Jun 2021 | Jun 02, 2024 | Issued |
| MDR QMS | 20M00129CRT04 | FEops NV | MDR | Sep 2021 | Sep 28, 2024 | Issued |
| MDR QMS | 19M00153CRT01 | Heater Cooler B.V. | MDR | Oct 2021 | Oct 06, 2024 | Issued |
| MDR QMS | 20M00011CRT02 | Corsano Health BV | MDR | Nov 2021 | Nov 15, 2024 | Issued |
| MDR QMS | 21M00054CRT02 | Reboocon Bionics B.V. | MDR | Dec 2021 | Dec 02, 2024 | Issued |
| MDR QMS | 20M00153CRT02 | Peercode B.V. | MDR | Jan 2022 | Jan 24, 2025 | Issued |
| MDR QMS | 20M00120CRT02 | piur imaging GmbH | MDR | Feb 2022 | Feb 01, 2025 | Issued |
| MDR QMS | 21M00066CRT02 | Fysicon B.V. | MDR | Oct 2024 | Mar 14, 2025 | Amended |
| MDR QMS | 20M00107CRT01 | FLUIDDA NV | MDR | Jun 2022 | Jun 21, 2025 | Issued |
| MDR QMS | 22M00055CRT01 | smartQare BV | MDR | Aug 2022 | Aug 24, 2027 | Issued |
| MDR QMS | 21M00198CRT01 | TeMeCo B.V. | MDR | Sep 2022 | Sep 29, 2027 | Issued |
| MDR QMS | 21M00068CRT01 | Doc2U | MDR | Oct 2022 | Oct 24, 2027 | Issued |
| MDR QMS | 20M00084CRT02 | I-SMART DEVELOPMENTS LIMITED | MDR | Mar 2023 | Mar 09, 2028 | Issued |
| MDR QMS | 23M00031CRT01 | Prolira BV | MDR | Jun 2023 | Jun 17, 2028 | Withdrawn |
| MDR QMS | 21M00096CRT01 | FastFocus B.V. | MDR | Jun 2023 | Jun 29, 2028 | Issued |
| MDR QMS | 22M00047CRT01 | Relu B.V. | MDR | Jul 2023 | Jul 18, 2028 | Issued |
| MDR QMS | 23M00032CRT01 | Nemo Healthcare B.V. | MDR | Sep 2023 | Sep 28, 2028 | Issued |
| MDR QMS | 21M00147CRT01 | Diappymed | MDR | Oct 2023 | Oct 04, 2028 | Issued |
| MDR QMS | 23M00065CRT01 | MRIguidance B.V. | MDR | Dec 2023 | Dec 02, 2028 | Issued |
| MDR QMS | 23M00082CRT01 | ArtiQ NV | MDR | Jan 2024 | Jan 15, 2029 | Issued |
| MDR QMS | 23M00044CRT01 | Cryo Products B.V. | MDR | Feb 2024 | Feb 09, 2029 | Issued |
| MDR QMS | 21M00123CRT01 | Limbus AI Inc. | MDR | Mar 2024 | Mar 01, 2029 | Issued |
| MDR QMS | 23M00184CRT01 | Intelligent Ultrasound Limited | MDR | Apr 2024 | Apr 08, 2029 | Issued |
| MDR QMS | 23M00187CRT01 | Dear Health Holding Company B.V. | MDR | Jun 2024 | Jun 02, 2029 | |
| MDR QMS | 22M00045CRT01 | Sycai Technologies S.L. | MDR | Jul 2024 | Jul 25, 2029 | Issued |
| MDR QMS | 21M00170CRT01 | Augere Medical AS | MDR | Aug 2024 | Aug 07, 2029 | Issued |
| MDR QMS | 21M00172CRT01 | Smart Soft Healthcare | MDR | Aug 2024 | Aug 27, 2029 | Issued |
| MDR QMS | 24M00068CRT01 | FEops NV | MDR | Sep 2024 | Sep 28, 2029 | |
| MDR QMS | 21M00061CRT01 | Occuity Limited | MDR | Sep 2024 | Sep 30, 2029 | Issued |
| MDR QMS | 24M00085CRT01 | Heater Cooler B.V. | MDR | Oct 2024 | Oct 06, 2029 | |
| MDR QMS | 21M00098CRT01 | INNOVATION SPRINT SRL | MDR | Dec 2024 | Dec 17, 2029 | Issued |
| MDR QMS | 22M00016CRT01 | WeDiagnostiX | MDR | Jan 2025 | Jan 13, 2030 | Issued |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| Intelligent Ultrasound Limited | 2 | 1 | 0 | |
| FEops NV | 🇧🇪 Belgium | 2 | 1 | 0 |
| Dear Health Holding Company B.V. | 🇳🇱 Netherlands | 2 | 1 | 0 |
| Heater Cooler B.V. | 🇳🇱 Netherlands | 2 | 1 | 0 |
| Relu B.V. | 🇧🇪 Belgium | 1 | 1 | 0 |
| Reboocon Bionics B.V. | 🇳🇱 Netherlands | 1 | 0 | 0 |
| Peercode B.V. | 🇳🇱 Netherlands | 1 | 0 | 0 |
| piur imaging GmbH | 🇦🇹 Austria | 1 | 0 | 0 |
| Nemo Healthcare B.V. | 🇳🇱 Netherlands | 1 | 1 | 0 |
| I-SMART DEVELOPMENTS LIMITED | 1 | 1 | 0 | |
| MRIguidance B.V. | 🇳🇱 Netherlands | 1 | 1 | 0 |
| FLUIDDA NV | 🇧🇪 Belgium | 1 | 0 | 0 |
| Doc2U | 🇫🇷 France | 1 | 1 | 0 |
| Diappymed | 🇫🇷 France | 1 | 1 | 0 |
| FastFocus B.V. | 🇳🇱 Netherlands | 1 | 1 | 0 |
| RELEGS BV | 🇳🇱 Netherlands | 1 | 0 | 0 |
| Inion Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| NICo-Lab B.V. | 🇳🇱 Netherlands | 1 | 0 | 0 |
| smartQare BV | 🇳🇱 Netherlands | 1 | 1 | 0 |
| ArtiQ NV | 🇧🇪 Belgium | 1 | 1 | 0 |
| TeMeCo B.V. | 🇳🇱 Netherlands | 1 | 1 | 0 |
| Cryo Products B.V. | 🇳🇱 Netherlands | 1 | 1 | 0 |
| Limbus AI Inc. | 🇨🇦 Canada | 1 | 1 | 0 |
| Corsano Health BV | 🇳🇱 Netherlands | 1 | 0 | 0 |
| Sycai Technologies S.L. | 🇪🇸 Spain | 1 | 1 | 0 |
| Augere Medical AS | 🇳🇴 Norway | 1 | 1 | 0 |
| Occuity Limited | 1 | 1 | 0 | |
| Smart Soft Healthcare | 🇧🇬 Bulgaria | 1 | 1 | 0 |
| Fysicon B.V. | 🇳🇱 Netherlands | 1 | 0 | 0 |
| Prolira BV | 🇳🇱 Netherlands | 1 | 0 | 0 |
| INNOVATION SPRINT SRL | 🇧🇪 Belgium | 1 | 1 | 0 |
| WeDiagnostiX | 🇫🇷 France | 1 | 1 | 0 |