EU Manufacturer
🇺🇸 United States
Active
ivWatch, LLC
SRN: US-MF-000001531
·
Tech Center Parkway 700, 23606 Newport News, United States
Basic UDI-DIs
7
Total Devices
7
On Market
7
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
2
Basic Information
- Address
- Tech Center Parkway 700, 23606 Newport News, United States
- [email protected]
- Phone
- 18554892824
- Website
- www.ivwatch.com
Regulatory Overview
Regulation
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Eu Mdr
4
Eu Mdd
3
Classification
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Eu Md Class 1
4
Eu Md Class 2a
3
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 095360 0016 | TÃœV SÃœD Product Service GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 2 countries across Europe.
🇮🇹 Italy
🇳🇱 Netherlands
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ivWatch Extension Module | EU MDD | Eu Md Class 2a | On Market | 1 |
| ivWatch Fiber Optic Sensor Cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| ivWatch Patient Cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| ivWatch Patient Monitor | EU MDD | Eu Md Class 2a | On Market | 1 |
| ivWatch Patient Monitor | EU MDD | Eu Md Class 2a | On Market | 1 |
| ivWatch Sensor Receptacle | EU MDR | Eu Md Class 1 | On Market | 0 |
| ivWatch SmartTouch Sensor | EU MDR | Eu Md Class 1 | On Market | 0 |