Identity
- Device Name
- Full Body Garment EUDAMED
- Model / Reference
- FB001 EUDAMED2018XGGPESSREXP2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899347735019 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
Category: Compression/pressure sock/stocking, single-use
Full Body Garment by Macom Malhas de Compressao Ltda — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 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 fcd1c720-8f04-41ca-808f-a47ef4687493 61 fields · synced Sep 18, 2026