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Mesh Abdominal Binder
EUDAMEDClass I (EU MDR)
Ref 2268-BG-M-1Ref 2268-BG-XL-1Ref 2268-BG-S-1Ref 2268-BG-XXL-1
Identity
- Trade Name
- Mesh Abdominal Binder EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 2268-BG-M-1 EUDAMED2268-BG-XL-1 EUDAMED2268-BG-S-1 EUDAMED2268-BG-XXL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863698663 EUDAMED04719863698687 EUDAMED04719863698656 EUDAMED04719863698694 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
Mesh Abdominal Binder 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 (4)
- EUDAMED e2b5dcaa-fec9-48a6-aba0-8b41abc96fc6 61 fields · synced Oct 6, 2026
- EUDAMED f46b4b15-6803-432d-8f75-411c9643f45b 61 fields · synced May 17, 2026
- EUDAMED a3b1f116-0ac6-42cb-b7bf-f1ec98830296 61 fields · synced May 17, 2026
- EUDAMED 915f287e-5643-40b5-882c-4eb72028ebd3 61 fields · synced May 17, 2026