Identity
- Device Name
- Unisex abdominal binder EUDAMED
- Model / Reference
- 122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05712690004439 EUDAMED
- Basic UDI-DI
- 571269000009A6 EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Compression/pressure sock/stocking, reusable
Unisex abdominal binder is a medical device designed for the treatment of various conditions, including gastrointestinal disorders. This device provides a secure and comfortable way to support and stabilize patients during medical procedures. Unisex abdominal binders are used in emergency situations when standard restraints are not available or necessary.
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Also classified as Compression/pressure sock/stocking, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 571269000009A6 | Class I | Active |
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Manufacturer
- Manufacturer
- Eto Garments ApS
- EUDAMED SRN
- DK-MF-000002251
Sources (1)
- EUDAMED 1873f3e4-7d1a-44ae-a13c-87b15e720371 61 fields · synced Aug 1, 2026