Elastic Shoulder Immobilizer
by Medequip Healthcare Solutions Pvt Ltd 2 variants
Ref Elastic Shoulder Immobilizer (M), Elastic Shoulder Immobilizer (XXL), Elastic Shoulder Immobilizer (L), Elastic Shoulder Immobilizer (S)
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 | Number890617612M302D3 | Date26 Mar 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- Withdrawn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
- Elastic Shoulder Immobilizer
- Model / Reference
- Elastic Shoulder Immobilizer (M), Elastic Shoulder Immobilizer (XXL), Elastic Shoulder Immobilizer (L), Elastic Shoulder Immobilizer (S)
- Primary DI / UDI-DI
- 08906176120875, 08906176120905, 08906176120882, 08906176120868
- Basic UDI-DI
- 890617612M302D3
- Direct Marketing DI
- 08906176120875089061761209050890617612088208906176120868
- EMDN Code
- Y060621 Shoulder orthoses
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- IN-MF-000039598
- Authorised representative
- AF Pharma Service Europe SL ES-AR-000018076
Other devices from Medequip Healthcare Solutions Pvt Ltd
See all devices from Medequip Healthcare Solutions Pvt Ltd →
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