Identity
- Device Name
- Knee Orthoses EUDAMED
- Model / Reference
- 80-011-U4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719883171085 EUDAMED
- Basic UDI-DI
- 471988317MN7XN4 EUDAMED
- Direct Marketing DI
- 04719883171085 EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Knee Orthoses by Mammon International Corp. — 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 | 471988317MN7XN4 | Class I | Active |
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Manufacturer
- Manufacturer
- Mammon International Corp.
- EUDAMED SRN
- TW-MF-000011691
- Authorised Representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Sources (1)
- EUDAMED f1b8b768-c27e-4c7a-8d86-24a3b5fe7f0d 61 fields · synced Jul 10, 2026