Identity
- Device Name
- Lower Extremity EUDAMED
- Model / Reference
- Lower Extremity EUDAMEDRP225 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719882320637 EUDAMED
- Basic UDI-DI
- 471988232LOTM00017M EUDAMED
- Direct Marketing DI
- 04719882320637 EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Lower Extremity by Unitrend Co., Ltd. — 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 | 471988232LOTM00017M | Class I | Active |
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Manufacturer
- Manufacturer
- Unitrend Co., Ltd.
- EUDAMED SRN
- TW-MF-000012250
- Authorised Representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Sources (1)
- EUDAMED 145e5e63-9dce-4521-aa8e-68d4183ccf31 61 fields · synced Jul 12, 2026