Hugo RAS MRASI0001
by Covidien LP EUDAMEDGUDID
Active
Ref MRASI0001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0763000B000063987 | Date14 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10884521826694 | Date2 Jan 2026 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- Trade Name
- Hugo™ EUDAMEDHugo RAS GUDID
- Generic Name
- Robotic endoscopic electrosurgical instrument, monopolar, reusable
- Model / Reference
- MRASI0001
- Primary DI / UDI-DI
- 10884521826694
- Basic UDI-DI
- 0763000B000063987
- Direct Marketing DI
- 10884521826694
- 510(k) Number
- FDA Product Code
- SCV
- EMDN Code
- L1399 Robotic surgery instruments, reusable - other
- GMDN Term
- Robotic endoscopic electrosurgical instrument, monopolar, reusable
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 878.4964
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Other devices from Covidien LP
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No