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Abdominal Binder
EUDAMEDClass I (EU MDR)
Ref 2160-BG-XXL-1Ref 2060-BG-M-1Ref 2160-BG-M-1Ref 2160-BG-S-1Ref 2162-BG-S-1Ref 2162-BG-XXL-1Ref 2060-BG-XL-1Ref 2060-BG-L-1
Identity
- Trade Name
- Abdominal Binder EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 2160-BG-XXL-1 EUDAMED2060-BG-M-1 EUDAMED2160-BG-M-1 EUDAMED2160-BG-S-1 EUDAMED2162-BG-S-1 EUDAMED2162-BG-XXL-1 EUDAMED2060-BG-XL-1 EUDAMED2060-BG-L-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863691756 EUDAMED04719863691671 EUDAMED04719863691725 EUDAMED04719863691718 EUDAMED04719863693873 EUDAMED04719863697062 EUDAMED04719863691695 EUDAMED04719863691688 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 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 (8)
- EUDAMED 09476a03-ab13-48b0-a3d8-6953e7409f42 61 fields · synced Oct 6, 2026
- EUDAMED b6f0935a-de12-4865-83d0-a5c51d081b2c 61 fields · synced May 16, 2026
- EUDAMED 68f82918-6083-4b19-8a8a-b970727ee82b 61 fields · synced May 17, 2026
- EUDAMED 5e306f35-0b1a-4272-8972-f5b75da58f40 61 fields · synced May 17, 2026
- EUDAMED ffa3f266-603b-4adf-9b81-30f3fcdb3987 61 fields · synced May 18, 2026
- EUDAMED 82632245-218f-4361-85e4-cdec01db72c6 61 fields · synced May 18, 2026
- EUDAMED ad53b023-0710-4281-b726-742163f5257a 61 fields · synced May 18, 2026
- EUDAMED 0378261f-0fed-4ceb-b0bd-cc8351af0bf3 61 fields · synced May 19, 2026