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Saebo
EUDAMEDClass I (EU MDR)
Ref X1-FX-1-CU-N-1Model SaeboFlex Orthosis, Custom
by Saebo Inc.
Identity
- Trade Name
- Saebo EUDAMED
- Device Name
- SaeboFlex Orthosis, Custom EUDAMED
- Model / Reference
- SaeboFlex Orthosis, Custom EUDAMEDX1-FX-1-CU-N-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810018350161 EUDAMED
- Basic UDI-DI
- 0850331006SaeboFlexPH EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Saebo by Saebo Inc. — 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 | 0850331006SaeboFlexPH | Class I | Active |
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Manufacturer
- Manufacturer
- Saebo Inc.
- EUDAMED SRN
- US-MF-000052039
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 2fa1da98-765d-4ab0-b0ed-7d7ade7c5394 61 fields · synced May 22, 2026