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XM Extremity Movement Sensor
EUDAMEDFDA UDIClass I (EU MDR)
Ref 12-10180-0001Model XM Extremity Movement SensorRef 13-50000-0050
Identity
- Trade Name
- XM Extremity Movement Sensor EUDAMEDTriplePlay FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Movement Sensor EUDAMEDInterface Cable, Limb Movement FDA UDI
- Model / Reference
- XM Extremity Movement Sensor EUDAMED12-10180-0001 EUDAMEDFDA UDI13-50000-0050 EUDAMED
- Description
- Interface Cable, Limb Movement FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817377022432 EUDAMEDFDA UDI20817377023112 EUDAMED
- Basic UDI-DI
- 08173770213500008P EUDAMED
- Unit of Use DI
- 00817377023118 EUDAMED
- Direct Marketing DI
- 00817377022432 EUDAMED
- 510(k) Number
- K990321 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
XM Extremity Movement Sensor by Dymedix Diagnostics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08173770213500008P | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dymedix Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000015691
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (3)
- EUDAMED 688d92f1-1a6e-42a2-a93c-9e1006e19e11 61 fields · synced Jul 15, 2026
- EUDAMED d506a3fe-136f-4f4d-804b-f202e385096b 61 fields · synced May 18, 2026
- FDA UDI 842c1927-1985-4eab-a785-1c8c10c9b536 34 fields · synced May 30, 2026