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Shoulder Activator
EUDAMEDClass I (EU MDR)
Ref 2970-GY-XXXL-1Ref 2970-GY-M-1Ref 2970-GY-L-1Ref 2970-GY-XL-1Ref 2970-GY-S-1Ref 2970-GY-XXL-1
Identity
- Trade Name
- Shoulder Activator EUDAMED
- Device Name
- ORTHOSES, UPPER EXTREMITY EUDAMED
- Model / Reference
- 2970-GY-XXXL-1 EUDAMED2970-GY-M-1 EUDAMED2970-GY-L-1 EUDAMED2970-GY-XL-1 EUDAMED2970-GY-S-1 EUDAMED2970-GY-XXL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769157244 EUDAMED04711769156384 EUDAMED04711769156391 EUDAMED04711769156407 EUDAMED04711769156377 EUDAMED04711769156414 EUDAMED
- Basic UDI-DI
- 471986369CL103DH EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Shoulder Activator by OPPO Medical Corp. — 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 | 471986369CL103DH | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Corp.
- EUDAMED SRN
- TW-MF-000005201
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (6)
- EUDAMED 9885cd7a-9406-4907-a138-59c3ea647677 61 fields · synced Oct 6, 2026
- EUDAMED 0ebdcfa1-5b73-4771-84b7-804d125c12d0 61 fields · synced May 17, 2026
- EUDAMED 8cddcb93-2458-40fe-96ea-5807bf8db32e 61 fields · synced May 18, 2026
- EUDAMED 35a80518-e2aa-4a93-afd5-e6ef02cb0a40 61 fields · synced May 19, 2026
- EUDAMED 3948ce61-5091-4568-bf61-9e4b75c3898a 61 fields · synced May 19, 2026
- EUDAMED 792b3012-0b3e-4934-86c3-56cf2fd9cd39 61 fields · synced May 19, 2026