Finger (premium) 2 digits
Ref ASC71F-2Model ASC****
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 | Number50553482ASCTU 50553482004714 | Date28 Nov 2024 | 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- Withdrawn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
- High-Definition Custom Silicone
- Model / Reference
- ASC****, ASC71F-2
- Primary DI / UDI-DI
- 50553482004714
- Basic UDI-DI
- 50553482ASCTU
- EMDN Code
- Y061803 Partial hand prostheses (including fingers prostheses)
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- GB-MF-000010196
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Hugh Steeper Limited
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