Identity
- Device Name
- Breast and arm compression garment EUDAMED
- Model / Reference
- H601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05712690014803 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
Category: Compression/pressure sock/stocking, reusable
Breast and arm compression garment by Eto Garments ApS — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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
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 1fdbdeb2-9b30-4dcb-b5ee-997eab5f7d92 61 fields · synced Jul 30, 2026