EU Manufacturer
🇫🇷 France
Active
ROBOCATH S.A.S
SRN: FR-MF-000003651
·
rue Marie Curie 19, 76000 ROUEN, France
Basic UDI-DIs
3
Total Devices
6
On Market
3
Off Market
3
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
8
Basic Information
- Address
- rue Marie Curie 19, 76000 ROUEN, France
- [email protected]
- Phone
- +33 2 32 10 67 42
- Website
- https://www.robocath.com/
Regulatory Overview
Regulation
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Eu Mdd
2
Eu Mdr
1
Classification
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Eu Md Class 2b
2
Eu Md Class 1
1
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Expired / Withdrawn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) | CE 690387 | BSI Group The Netherlands B.V. | Feb 17, 2024 |
Market Presence
Devices from this manufacturer are available in 8 countries across Europe.
🇧🇪 Belgium
🇩🇪 Germany
🇪🇸 Spain
🇫🇷 France
🇮🇹 Italy
🇱🇺 Luxembourg
🇳🇱 Netherlands
🇵🇱 Poland
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Kit Consommable R-One | EU MDD | Eu Md Class 1 | Off Market | 1 |
| R-One Robotic Platform | EU MDR | Eu Md Class 2b | Off Market | 0 |
| R-One Robotic Platform | EU MDR | Eu Md Class 2b | On Market | 0 |
| R-One Robotic Platform | EU MDD | Eu Md Class 2b | On Market | 1 |
| R-One Robotplatform | EU MDR | Eu Md Class 2b | Off Market | 0 |
| R-One Robotplatform | EU MDR | Eu Md Class 2b | On Market | 0 |