Identity
- Trade Name
- Malleo Comfort - XL EUDAMED
- Device Name
- Malleo Comfort EUDAMED
- Model / Reference
- PO 31704 EUDAMEDPO 31704 XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08718873000974 EUDAMED
- Basic UDI-DI
- 871887331704MB EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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: Ankle/foot orthosis
Malleo Comfort - XL by Lomed Nederland — 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 | 871887331704MB | Class I | Active |
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Manufacturer
- Manufacturer
- Lomed Nederland
- EUDAMED SRN
- NL-MF-000032807
Sources (1)
- EUDAMED 7ac36a06-a6a7-44db-9a7c-81449cfc4db4 61 fields · synced Jun 18, 2026