Identity
- Device Name
- Full Body Garment EUDAMED
- Model / Reference
- FB001 EUDAMED2023BLBBLXPPBESSREXP3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899347752610 EUDAMED
- Basic UDI-DI
- 78993477FB001UA EUDAMED
- EMDN Code
- M030405 COMPRESSION STOCKINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Full Body 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 | 78993477FB001UA | 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 cb8a3259-44cb-4a00-ad90-032ff7a071e0 61 fields · synced Aug 3, 2026