Shoulder Abduction Immobilizer
by Orthotech Rehabilitation Co., Ltd. EUDAMED
Active
Ref 213101(S/UNI/Gray&Silver), 213101(M/UNI/Gray&Silver), 213101(L/UNI/Gray&Silver), 213101(XL/UNI/Gray&Silver)Model Mesh Sling:210001 TC Sling:210002 Universal Swathe Sling:210003 Shoulder Support:210004 Humeral Fracture Brace:210005 Shoulder Immobilizer:210008 Shoulder Abduction Immobilizer:213101 Pillow Arm ABD Immobilizer:213103 etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number47199644621W6 | Date14 Apr 2026 | 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- Withdrawn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
- Shoulder Sling (Shoulder immobilizer/orthosis and shoulder strap orthosis)
- Model / Reference
- Mesh Sling:210001 TC Sling:210002 Universal Swathe Sling:210003 Shoulder Support:210004 Humeral Fracture Brace:210005 Shoulder Immobilizer:210008 Shoulder Abduction Immobilizer:213101 Pillow Arm ABD Immobilizer:213103 etc, 213101(S/UNI/Gray&Silver), 213101(M/UNI/Gray&Silver), 213101(L/UNI/Gray&Silver), 213101(XL/UNI/Gray&Silver)
- Primary DI / UDI-DI
- 04719892935166, 04719892935159, 04719892935142, 04719892935173
- Basic UDI-DI
- 47199644621W6
- EMDN Code
- Y060621 Shoulder orthoses
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000051924
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Orthotech Rehabilitation Co., 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