Incrediwear® Golf Sock Performance
by Incrediwear Holdings, Inc. 3 variants
Ref RG301, RG204, RG203, RG102, RG103, RG304, RG302, RG202, RG303
Withdrawn
CE MDR, withdrawn
Ended
Withdrawn
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0891709000APPARELEZ | Date11 Oct 2021 | StatusWithdrawn |
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- Withdrawn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European Union — CE/MDR Withdrawn
Specification
- Device Name
- Apparel
- Model / Reference
- RG301, RG204, RG203, RG102, RG103, RG304, RG302, RG202, RG303
- Primary DI / UDI-DI
- 00851791006487, 00851791006470, 00851791006463, 00851791006418, 00851791006425, 00851791006517, 00851791006494, 00851791006456, 00851791006500
- Basic UDI-DI
- 0891709000APPARELEZ
- EMDN Code
- M030402010103 Elastic support bandages, non-adhesive, extensible in two directions, high extensibility
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000012639
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Incrediwear Holdings, Inc.
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