Identity
- Device Name
- 12'' ABDOMINAL BINDER EUDAMED
- Model / Reference
- 8639WHIL/X EUDAMED8639WHIS/M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05028318232161 EUDAMED05028318232154 EUDAMED
- Basic UDI-DI
- 7631898639DG EUDAMED
- EMDN Code
- Y060403 ABDOMINAL MUSCLES SUPPORTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
12'' Abdominal Binder by Elastic Therapy — 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 | 7631898639DG | Class I | Active |
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Manufacturer
- Manufacturer
- Elastic Therapy
- EUDAMED SRN
- US-MF-000021563
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED eb4802ac-da02-4a26-b1e6-1a6bdf5458b7 61 fields · synced Jul 31, 2026
- EUDAMED a8baaaf7-8015-423d-a083-35acb47cf806 61 fields · synced May 18, 2026