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Evo Docking Station Usb Conn & Eu Pwr Cbl
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50-0044Model EVO Docking Station
Identity
- Trade Name
- EVO DOCKING STATION USB CONN & EU PWR CBL EUDAMEDEVO FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- EVO EUDAMEDEVO DOCKING STATION USB CONN & EU PWR CBL FDA UDI
- Model / Reference
- EVO Docking Station EUDAMEDFDA UDI50-0044 EUDAMED
- Description
- EVO DOCKING STATION USB CONN & EU PWR CBL FDA UDI
Identifiers
- Catalog Number
- 50-0044 FDA UDI
- Primary DI / UDI-DI
- 10841522125430 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221IEVODOCKOWNHX EUDAMED
- Direct Marketing DI
- 10841522125430 EUDAMED
- FDA Product Code
- MWJ FDA UDI
- EMDN Code
- Z12050499 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS – OTHER EUDAMED
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Evo Docking Station Usb Conn & Eu Pwr Cbl by Spacelabs Healthcare Ltd — 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 | 08415221IEVODOCKOWNHX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Spacelabs Healthcare Ltd
- EUDAMED SRN
- GB-MF-000001196
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED aecf9d27-9950-4fc8-b109-8188dd669581 61 fields · synced Jun 19, 2026
- FDA UDI a619e9fb-e4c3-4550-821c-79757144da9b 36 fields · synced May 30, 2026