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TC Sling
EUDAMEDClass I (EU MDR)
Ref 210002(L/UNI/Gray&Silver)Model Arm ABD Immobilizer:213106 Arm ABD Immobilizer:213107 Arm ABD Immobilizer:213108 Humeral Fracture Brace:210005 Mesh Sling:210001 Pillow Arm ABD Immobilizer:213103 Shoulder Abduction Immobilizer:213101 etc
Identity
- Trade Name
- TC Sling EUDAMED
- Device Name
- Shoulder Sling (Shoulder immobilizer/orthosis and shoulder strap orthosis) EUDAMED
- Model / Reference
- Arm ABD Immobilizer:213106 Arm ABD Immobilizer:213107 Arm ABD Immobilizer:213108 Humeral Fracture Brace:210005 Mesh Sling:210001 Pillow Arm ABD Immobilizer:213103 Shoulder Abduction Immobilizer:213101 etc EUDAMED210002(L/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872860471 EUDAMED
- Basic UDI-DI
- 47198728621W8 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 Zhangpu Ortholife 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 | 47198728621W8 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 5b3ebe42-37a5-4771-8efe-6eb5845b148e 61 fields · synced Oct 8, 2026