Identity
- Trade Name
- Inserts EUDAMED
- Device Name
- Inserts EUDAMED
- Model / Reference
- FI001 EUDAMED91UNIBEXP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899347795983 EUDAMED
- Basic UDI-DI
- 78993477FI001VT EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER 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
Inserts 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 | 78993477FI001VT | 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 31b2b06b-c25e-47cc-8e3d-be787277d58a 61 fields · synced Jul 21, 2026