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Abdominal Support
EUDAMEDClass I (EU MDR)
Ref 2360-GB-L-1Ref 2360-GB-S-1Ref 2360-GB-XXL-1Ref 2260-BG-S-1Ref 2360-GB-M-1
Identity
- Trade Name
- Abdominal Support EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 2360-GB-L-1 EUDAMED2360-GB-S-1 EUDAMED2360-GB-XXL-1 EUDAMED2260-BG-S-1 EUDAMED2360-GB-M-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716609639645 EUDAMED04716609639621 EUDAMED04716609639669 EUDAMED04719863691763 EUDAMED04716609639638 EUDAMED
- Basic UDI-DI
- 471986369CL104DK EUDAMED
- EMDN Code
- Y060399 SPINE ORTHOSES - 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
Yes
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
Abdominal Support 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 | 471986369CL104DK | 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 (5)
- EUDAMED 5617a324-5f91-4972-879d-e20fef2f06df 61 fields · synced Jul 31, 2026
- EUDAMED 8478557c-c5f2-44d9-bc33-b0ea5c47729f 61 fields · synced May 16, 2026
- EUDAMED bf368b3d-b620-42ec-b348-6effb51e0852 61 fields · synced May 17, 2026
- EUDAMED 10e13e02-74ed-4959-b7c5-a632002be50b 61 fields · synced May 17, 2026
- EUDAMED 0b3fde59-ea17-4050-980b-55cab6ff358e 61 fields · synced May 19, 2026