NICE1
by Nice Recovery Systems LLC 30 variants
Ref 40127
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0850014566401277F 00850014566456 | Date20 May 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- NICE1 Total Shoulder, Right, L/XL
- Model / Reference
- 40127
- Primary DI / UDI-DI
- 00850014566456
- Basic UDI-DI
- 0850014566401277F
- EMDN Code
- M9001, Z120607
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000018331
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Nice Recovery Systems, LLC
Properties
Other properties (13)
- Sterile: 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