Identity
- Trade Name
- Ear Garment EUDAMED
- Device Name
- Leg, Arm and Ear Garments EUDAMED
- Model / Reference
- LA001 EUDAMED4005PPEXP1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899347700444 EUDAMED
- Basic UDI-DI
- 78993477LA001W5 EUDAMED
- EMDN Code
- M030405 COMPRESSION STOCKINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Ear Garment by Macom Malhas de Compressao Ltda — 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 | 78993477LA001W5 | Class I | Active |
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Manufacturer
- Manufacturer
- Macom Malhas de Compressao Ltda
- EUDAMED SRN
- BR-MF-000048997
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED e74fee88-00dd-4fa1-9d04-0850e16dd25b 61 fields · synced Aug 1, 2026