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MapleLeaf Hip Orthosis - Modular HIP XS THIGH LG
EUDAMEDClass I (EU MDR)
Ref 147-MOD-XS-LModel Maple Leaf
Identity
- Trade Name
- MapleLeaf Hip Orthosis - Modular HIP XS THIGH LG EUDAMED
- Device Name
- Maple Leaf Orthosis EUDAMED
- Model / Reference
- Maple Leaf EUDAMED147-MOD-XS-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545161903 EUDAMED
- Basic UDI-DI
- 194545MPLYE EUDAMED
- EMDN Code
- Y061215 HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
MapleLeaf Hip Orthosis - Modular HIP XS THIGH LG by Becker Orthopedic Appliance Company — 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 | 194545MPLYE | Class I | Active |
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Manufacturer
- Manufacturer
- Becker Orthopedic Appliance Company
- EUDAMED SRN
- US-MF-000004002
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED b1fd8ccb-3f76-41fd-829b-e28f13850cef 61 fields · synced Jul 15, 2026