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Arm ABD Immobilizer
EUDAMEDClass I (EU MDR)
Ref 213108(Universal/Right/Black)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 etcRef 213108(Universal/Left/Black)
Identity
- Trade Name
- Arm ABD Immobilizer EUDAMED
- Device Name
- Shoulder Sling (Shoulder immobilizer/orthosis and shoulder strap orthosis) EUDAMED
- 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 EUDAMED213108(Universal/Right/Black) EUDAMED213108(Universal/Left/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964463375 EUDAMED04719964463368 EUDAMED
- Basic UDI-DI
- 47199644621W6 EUDAMED
- EMDN Code
- Y060621 SHOULDER ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Arm ABD Immobilizer by Orthotech Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 47199644621W6 | Class I | Active |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED c42f49bb-85d9-4493-8499-938fbde27e85 61 fields · synced Oct 6, 2026
- EUDAMED afd9a03b-d706-41de-adb7-3070b8c7cf28 61 fields · synced May 19, 2026