R-Star Robotic Unit Drape
by Advance Medical Designs, Inc.
Ref RBH02C1000
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number84834000RBH02C1000T3 00848340020391 | Date7 May 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- LDPE Sterile Cover, R-Star Robotic Unit Drape
- Model / Reference
- RBH02C1000
- Primary DI / UDI-DI
- 00848340020391
- Basic UDI-DI
- 84834000RBH02C1000T3
- EMDN Code
- T030199 Covers, instruments and equipment - other
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000009790
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Advance Medical Designs, Inc.
Properties
Other properties (12)
- 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