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TC Sling
EUDAMEDClass I (EU MDR)
Ref 210002(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 etcRef 210002(S/UNI/Gray&Silver)Ref 210002(L/UNI/Gray&Silver)Ref 210002(M/UNI/Gray&Silver)
Identity
- Trade Name
- TC Sling 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 EUDAMED210002(XL/UNI/Gray&Silver) EUDAMED210002(S/UNI/Gray&Silver) EUDAMED210002(L/UNI/Gray&Silver) EUDAMED210002(M/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892935296 EUDAMED04719892935289 EUDAMED04719892935265 EUDAMED04719892935272 EUDAMED
- Basic UDI-DI
- 47199644621W6 EUDAMED
- EMDN Code
- Y060621 SHOULDER ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
TC Sling 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 (4)
- EUDAMED f91f4f63-6ba5-4c24-b2d1-d09ecb93cfd7 61 fields · synced Oct 6, 2026
- EUDAMED 2691198e-71ca-4010-b3fa-99a891fbb83f 61 fields · synced May 17, 2026
- EUDAMED 0a894952-7f39-42e9-889f-8b33bd2ad533 61 fields · synced May 17, 2026
- EUDAMED 3578bd08-0a83-475c-b494-2d82fe015b1d 61 fields · synced May 17, 2026