← Back to catalogue
Holter System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SE-3012Ref AI HolterRef SE-2012 Ref SE-2012ARef SE-2003Ref iSE-3012
Identity
- Trade Name
- Holter System EUDAMEDFDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- Holter System EUDAMED
- Model / Reference
- SE-3012 EUDAMEDAI Holter EUDAMEDSE-2012 EUDAMEDFDA UDISE-2003 EUDAMEDFDA UDISE-2012A EUDAMEDiSE-3012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413831834 EUDAMED06944413829008 EUDAMED06944413800977 EUDAMEDFDA UDI06944413800960 EUDAMEDFDA UDI06944413807686 EUDAMED06944413831889 EUDAMED
- Basic UDI-DI
- 69444138SE3012SFV EUDAMED69444138AIHolterW5 EUDAMED69444138SE2003SFG EUDAMED
- FDA Product Code
- MWJ FDA UDIDQK FDA UDI
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMEDZ12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI870.1425 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Yes
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
Holter System by Edan Instruments, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151787 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69444138SE3012SFV | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (9)
- EUDAMED ee6042c3-f98a-4797-b732-ffe22326178e 61 fields · synced Oct 1, 2026
- EUDAMED 544c1584-ffa1-4f15-a75e-d6bd5673f746 61 fields · synced May 18, 2026
- FDA UDI 9c08c521-ce2e-4f5c-9e60-fb231c73c27e 32 fields · synced May 30, 2026
- FDA UDI b24bf1b5-1d9c-4161-b345-c55047b68dac 32 fields · synced May 30, 2026
- EUDAMED bdd71dcf-630e-4a23-ac93-eb5300b9801c 61 fields · synced Jul 16, 2026
- EUDAMED 42a16fce-4082-4361-a43e-812bb9aa3d2f 61 fields · synced Aug 4, 2026
- EUDAMED b963cc0d-d9f7-4313-bac9-65f79871b42f 61 fields · synced Sep 18, 2026
- EUDAMED b57841b7-8dfb-48a9-8be9-273ff044048d 61 fields · synced Oct 1, 2026
- FDA 510(k) K151787 1 fields · synced May 18, 2026