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Lower Extremity Orthosis - Foot
EUDAMEDClass I (EU MDR)
Ref 22012Ref 22014Ref 22050Ref 22302Ref 22061Ref 22303Ref 22300Ref 22051Ref 27322Ref 22004Ref 27321
Identity
- Device Name
- Lower Extremity Orthosis - Foot EUDAMED
- Model / Reference
- 22012 EUDAMED22014 EUDAMED22050 EUDAMED22302 EUDAMED22061 EUDAMED22303 EUDAMED22300 EUDAMED22051 EUDAMED27322 EUDAMED22004 EUDAMED27321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00656204010651 EUDAMED00656204010675 EUDAMED00656204000164 EUDAMED00656204000263 EUDAMED00656204000928 EUDAMED00656204000270 EUDAMED00656204000249 EUDAMED00656204000171 EUDAMED00656204000560 EUDAMED00656204004988 EUDAMED00656204000553 EUDAMED
- Basic UDI-DI
- 065620461MC EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 Orthosis - Foot by Tiburon Medical Enterprises — 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 | 065620461MC | Class I | Active |
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Manufacturer
- Manufacturer
- Tiburon Medical Enterprises
- EUDAMED SRN
- US-MF-000012145
- Authorised Representative
- Code of Practice AB SE-AR-000003002
Sources (11)
- EUDAMED 0e705120-43c5-4640-a3c1-34d33eb87fa4 61 fields · synced Oct 6, 2026
- EUDAMED b62f0327-88d5-4e88-8086-4eb39ad4f62d 61 fields · synced May 16, 2026
- EUDAMED 95cc3e9b-d93c-42e7-84cf-5c3afb92ae55 61 fields · synced May 16, 2026
- EUDAMED fa3630a4-42d9-4f11-b124-73af901ce46e 61 fields · synced May 16, 2026
- EUDAMED 6abcf977-7936-4f01-a414-10d15762f00e 61 fields · synced May 17, 2026
- EUDAMED 8ca00975-a970-4610-afc0-afc836b1a76d 61 fields · synced May 17, 2026
- EUDAMED 58c6840e-7a23-4169-b7d4-a9f104498263 61 fields · synced May 17, 2026
- EUDAMED 7e2c58c7-d7fb-4da2-87ab-b38f2efdefd4 61 fields · synced May 17, 2026
- EUDAMED b8934cec-fdda-47ee-9257-dfee0c588149 61 fields · synced May 17, 2026
- EUDAMED 5f62f149-f5a0-4f9b-aeed-1ae19b971e73 61 fields · synced May 18, 2026
- EUDAMED 2de082d4-a2d9-4f95-a4be-edce54870848 61 fields · synced May 18, 2026