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XM Extremity Sensor
EUDAMEDClass I (EU MDR)
Ref 13-50000-0010Model XM Extremity Movement Sensor
Identity
- Trade Name
- XM Extremity Sensor EUDAMED
- Device Name
- Movement Sensor EUDAMED
- Model / Reference
- XM Extremity Movement Sensor EUDAMED13-50000-0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10817377023115 EUDAMED
- Basic UDI-DI
- 08173770213500008P EUDAMED
- Unit of Use DI
- 00817377023118 EUDAMED
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
XM Extremity Sensor by Dymedix Diagnostics, 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 | 08173770213500008P | Class I | Active |
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Manufacturer
- Manufacturer
- Dymedix Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000015691
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED f5150738-8a84-445e-b053-8f4eededbc22 61 fields · synced Jul 11, 2026