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Saebo
EUDAMEDClass I (EU MDR)
Ref R1-RE-1-CU-N-1Model SaeboReach Orthosis, Custom
by Saebo Inc.
Identity
- Trade Name
- Saebo EUDAMED
- Device Name
- SaeboReach Orthosis, Custom EUDAMED
- Model / Reference
- SaeboReach Orthosis, Custom EUDAMEDR1-RE-1-CU-N-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810018350178 EUDAMED
- Basic UDI-DI
- 0850331006SaeboReachVL EUDAMED
- EMDN Code
- Y060619 ELBOW-WRIST-HAND 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 | 0850331006SaeboReachVL | 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 bed7d238-b001-4b44-b8f5-62bfafda0f44 61 fields · synced May 22, 2026