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Saebo
EUDAMEDClass I (EU MDR)
Ref G1-GL-MD-MD-R-1Model SaeboGlove
by Saebo Inc.
Identity
- Trade Name
- Saebo EUDAMED
- Device Name
- SaeboGlove, Complete Kit, Shell EUDAMED
- Model / Reference
- SaeboGlove EUDAMEDG1-GL-MD-MD-R-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850331006345 EUDAMED
- Basic UDI-DI
- 0850331006SaeboGloveX5 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 is a cutting-edge medical device designed for comprehensive pain management, providing accurate and reliable results in the comfort of patient's homes. With its advanced technology and user-friendly interface, it offers a convenient alternative to traditional testing methods.
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 | 0850331006SaeboGloveX5 | 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 0d73b07d-7e9f-42dd-9b1c-75f30419c080 61 fields · synced Jul 8, 2026