Identity
- Device Name
- Breast and arm compression garment EUDAMED
- Model / Reference
- H601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05712690014797 EUDAMED
- Basic UDI-DI
- 5712690000029Q 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
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
Breast and arm compression garment by Eto Garments ApS — 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 | 5712690000029Q | Class I | Active |
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Manufacturer
- Manufacturer
- Eto Garments ApS
- EUDAMED SRN
- DK-MF-000002251
Sources (1)
- EUDAMED e43c4561-a1a0-4b4a-927d-3bb20908819f 61 fields · synced Sep 17, 2026