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Elbow Protector
EUDAMEDClass I (EU MDR)
Ref 2988-GY-XXL-1Ref 2988-GY-XXXL-1Ref 2988-GY-L-1Ref 2988-GY-XXXXL-1
Identity
- Trade Name
- Elbow Protector EUDAMED
- Device Name
- ORTHOSES, UPPER EXTREMITY EUDAMED
- Model / Reference
- 2988-GY-XXL-1 EUDAMED2988-GY-XXXL-1 EUDAMED2988-GY-L-1 EUDAMED2988-GY-XXXXL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769153550 EUDAMED04711769143896 EUDAMED04711769153536 EUDAMED04711769143902 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
Elbow Protector 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 (4)
- EUDAMED 1b833e75-33f7-48f5-914f-5264a8e4af75 61 fields · synced Oct 6, 2026
- EUDAMED fdb57b3b-5fb6-4b65-88ca-a55ad819dd8c 61 fields · synced May 17, 2026
- EUDAMED 5a2754ce-bbf3-4224-92ed-604a4be9a218 61 fields · synced May 17, 2026
- EUDAMED c07a97a7-df46-4605-8854-21944f68864d 61 fields · synced May 17, 2026