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Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 04.13.06.0001Model Model 1306
Identity
- Trade Name
- Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder EUDAMED12 CH ECG Holter ULTRA Recorder FDA UDI
- Model / Reference
- Model 1306 EUDAMEDFDA UDI04.13.06.0001 EUDAMED
- Description
- 12 CH ECG Holter ULTRA Recorder FDA UDI
Identifiers
- Catalog Number
- A10-1306-01 FDA UDI
- Primary DI / UDI-DI
- 00817980020184 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817980021306YJ EUDAMED
- 510(k) Number
- K111180 FDA UDI
- FDA Product Code
- DSH 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
- 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder by Vasomedical, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0817980021306YJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Vasomedical Inc.
- EUDAMED SRN
- US-MF-000030121
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (2)
- EUDAMED 36498252-ef71-47c1-a826-f568a219cdac 61 fields · synced Oct 5, 2026
- FDA UDI 82d56328-658d-4efe-9f38-615fbda16044 37 fields · synced May 30, 2026