← Back to catalogue
Arm ABD Immobilizer
EUDAMEDClass I (EU MDR)
Ref 213106(Universal/UNI/Black)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 etcRef 213103(M/UNI/Gray&Silver)Ref 213101(L/UNI/Gray&Silver)Ref 213101(XL/UNI/Gray&Silver)Ref 213101(S/UNI/Gray&Silver)Ref 213107(Universal/UNI/Black)Ref 213103(XL/UNI/Gray&Silver)Ref 213101(M/UNI/Gray&Silver)Ref 213108(Universal/Right/Black)
Identity
- Trade Name
- Arm ABD Immobilizer EUDAMEDPillow Arm ABD Immobilizer EUDAMEDShoulder Abduction Immobilizer 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 EUDAMED213106(Universal/UNI/Black) EUDAMED213103(M/UNI/Gray&Silver) EUDAMED213101(L/UNI/Gray&Silver) EUDAMED213101(XL/UNI/Gray&Silver) EUDAMED213101(S/UNI/Gray&Silver) EUDAMED213107(Universal/UNI/Black) EUDAMED213103(XL/UNI/Gray&Silver) EUDAMED213101(M/UNI/Gray&Silver) EUDAMED213108(Universal/Right/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872868880 EUDAMED04719872860754 EUDAMED04719872860358 EUDAMED04719872860389 EUDAMED04719872860372 EUDAMED04719872868897 EUDAMED04719872860778 EUDAMED04719872860365 EUDAMED04719872868910 EUDAMED
- Basic UDI-DI
- 47198728621W8 EUDAMED
- EMDN Code
- Y060621 SHOULDER ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMEDNetherlands EUDAMEDPoland 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 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (9)
- EUDAMED 2fc4ca26-cc6a-455f-b2bc-2a4e20af108c 61 fields · synced Oct 6, 2026
- EUDAMED f58ba828-3697-4947-aad9-46b4bc5c3ed8 61 fields · synced May 17, 2026
- EUDAMED 0e9d8977-79ab-4d32-a206-c3b70d7364f0 61 fields · synced May 17, 2026
- EUDAMED 5a4fc193-002a-47b7-895d-ecb657a07fae 61 fields · synced May 18, 2026
- EUDAMED 06e36a75-eb3c-4644-8f8f-3d013e031759 61 fields · synced May 18, 2026
- EUDAMED 65531efa-7031-4f41-9f3e-da92eb6c4768 61 fields · synced May 18, 2026
- EUDAMED cbb0911b-d290-4fa0-ba08-da2934ea011c 61 fields · synced May 18, 2026
- EUDAMED 3fbe5d76-3346-4736-a5f6-6d97f476b4ca 61 fields · synced May 18, 2026
- EUDAMED ed7523d4-36df-4337-a2f5-ad7dab44ac86 61 fields · synced May 19, 2026