Incrediwear® Elbow Sleeve
by Incrediwear Holdings, Inc. 4 variants
Ref G701b Red, G701b, G701, G701b Pink, G701 Royal, G701 Navy, G701 Pink, G701M Royal, G701M Navy, G701b Navy, G701 Red, G701M Pink
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 | Number0891709000SLEEVEA6 | Date11 Oct 2021 | 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- Withdrawn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
- Sleeve
- Model / Reference
- G701b Red, G701b, G701, G701b Pink, G701 Royal, G701 Navy, G701 Pink, G701M Royal, G701M Navy, G701b Navy, G701 Red, G701M Pink
- Primary DI / UDI-DI
- 00851791006920, 00891709000770, 00891709000473, 00850037219100, 00851791006937, 00851791006395, 00850037219087, 00851791006944, 00851791006883, 00851791006890, 00851791006906, 00850037219094
- Basic UDI-DI
- 0891709000SLEEVEA6
- 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