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4 Electrode Evo Recorder Packed
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 50-0034Model EVO Recorder
Identity
- Trade Name
- 4 ELECTRODE EVO RECORDER PACKED EUDAMEDSpacelabs Healthcare FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- EVO Recorder EUDAMED4 ELECTRODE EVO RECORDER PACKED FDA UDI
- Model / Reference
- EVO Recorder EUDAMED50-0034 EUDAMEDTAY FDA UDI
- Description
- 4 ELECTRODE EVO RECORDER PACKED FDA UDI
Identifiers
- Catalog Number
- 50-0034 FDA UDI
- Primary DI / UDI-DI
- 10841522125133 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221IIaTAYOWNJJ EUDAMED
- Direct Marketing DI
- 10841522125133 EUDAMED
- FDA Product Code
- MWJ FDA UDI
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
4 Electrode Evo Recorder Packed by Spacelabs Healthcare Ltd — Class IIa — 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 | 08415221IIaTAYOWNJJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 ecaaf4a7-0583-43c2-ab2b-a66871b7f800 61 fields · synced Jun 18, 2026
- FDA UDI a8a2f312-1099-4d36-a36d-b654eb3d9e42 36 fields · synced May 30, 2026