EU Manufacturer
๐บ๐ธ United States
Active
Invivo, a division of Philips Medical Systems
SRN: US-MF-000002177
ยท
Research Pkwy 12151, 32826 Orlando, United States
Basic UDI-DIs
22
Total Devices
67
On Market
67
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
27
Basic Information
- Address
- Research Pkwy 12151, 32826 Orlando, United States
- [email protected]
- Phone
- n/a
- Website
- n/a
Regulatory Overview
Regulation
Loading...
Eu Mdd
15
Eu Mdr
7
Classification
Loading...
Eu Md Class 2b
13
Eu Md Class 1
7
Eu Md Class 2a
2
Device Types
Loading...
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 41311197-02_Rev.2 | INTERTEK SEMKO AB | Jun 20, 2023 |
Market Presence
Devices from this manufacturer are available in 27 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Adult NBP Cuff | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adult NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adult SpO2 Clip | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adult-Long NBP Cuff | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adult-Long NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Audult SpO2 Grips (20) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Expression Information Portal (IP5) | EU MDD | Eu Md Class 2b | On Market | 1 |
| Expression MR400 MRI Patient Monitor Sys | EU MDD | Eu Md Class 2b | On Market | 1 |
| FlexTEMP II Sensor | EU MDD | Eu Md Class 2a | On Market | 1 |
| FlexTEMP System, Jacket | EU MDD | Eu Md Class 2a | On Market | 1 |
| Infant NBP Cuff | EU MDR | Eu Md Class 1 | On Market | 0 |
| Infant NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Infant Size 5 NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Infant SpO2 Grips (20) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Kit, Sample, Agents, 3160 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Large Adult NBP Cuff | EU MDR | Eu Md Class 1 | On Market | 0 |
| Large Adult NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Large Adult-Long NBP Cuff | EU MDR | Eu Md Class 1 | On Market | 0 |
| Large Adult-Long NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Long Extra Wide ECG 2.0 Cable AAMI | EU MDR | Eu Md Class 1 | On Market | 0 |
| Long Extra Wide ECG 2.0 Cable IEC | EU MDR | Eu Md Class 1 | On Market | 0 |
| Long Wide ECG 2.0 Cable AAMI | EU MDR | Eu Md Class 1 | On Market | 0 |
| Long Wide ECG 2.0 Cable IEC | EU MDR | Eu Md Class 1 | On Market | 0 |
| MR Patient Care Portal 5000 | EU MDD | Eu Md Class 2b | On Market | 1 |
| MR200 MRI Patient Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Multiple Patch ECG Electrodes (25) | EU MDR | Eu Md Class 1 | On Market | 0 |
| NIBP Cuff Sample Kit (8 piece) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Neonatal ECG 3.0 Cable AAMI | EU MDR | Eu Md Class 1 | On Market | 0 |
| Neonatal ECG 3.0 Cable IEC | EU MDR | Eu Md Class 1 | On Market | 0 |
| Neonatal ECG Electrodes (25) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Neonatal Size 1 NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Neonatal Size 2 NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Neonatal Size 3 NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Neonatal Size 4 NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Neonatal SpO2 Grips (20) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pediatric NBP Cuff | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pediatric NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pediatric SpO2 Clip | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pediatric SpO2 Grips (20) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Printer Kit, Strip Chart, USB | EU MDR | Eu Md Class 1 | On Market | 0 |
| Quick Connect SpO2 Probe, MRI | EU MDD | Eu Md Class 2b | On Market | 1 |
| Short Neonatal ECG 2.0 Cable AAMI | EU MDR | Eu Md Class 1 | On Market | 0 |
| Short Neonatal ECG 2.0 Cable IEC | EU MDR | Eu Md Class 1 | On Market | 0 |
| Short Standard ECG 2.0 Cable AAMI | EU MDR | Eu Md Class 1 | On Market | 0 |
| Short Standard ECG 2.0 Cable IEC | EU MDR | Eu Md Class 1 | On Market | 0 |
| Short Wide ECG 2.0 Cable AAMI | EU MDR | Eu Md Class 1 | On Market | 0 |
| Short Wide ECG 2.0 Cable IEC | EU MDR | Eu Md Class 1 | On Market | 0 |
| Single Patch ECG Electrodes (25) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Small Adult NBP Cuff | EU MDR | Eu Md Class 1 | On Market | 0 |
| Small Adult NBP Cuffs (10) | EU MDR | Eu Md Class 1 | On Market | 0 |