Incrediwear® Shoulder Brace
by Incrediwear Holdings, Inc. EUDAMED 2 variants
Active
Ref GR802
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0891709000BRACEWX | Date11 Oct 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Brace
- Model / Reference
- GR802
- Primary DI / UDI-DI
- 00858349003240
- Basic UDI-DI
- 0891709000BRACEWX
- EMDN Code
- M030402010103 Elastic support bandages, non-adhesive, extensible in two directions, high extensibility
- Device Class
- Class I
- 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