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Cardiovit Ft-1
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3.900863Model CARDIOVIT FT-1
by Schiller Ag
Identity
- Trade Name
- CARDIOVIT® FT-1 FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- CARDIOVIT FT-1 EUDAMEDThe CARDIOVIT® FT-1 is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings FDA UDI
- Model / Reference
- CARDIOVIT FT-1 EUDAMED3.900863 EUDAMEDFDA UDI
- Description
- The CARDIOVIT® FT-1 is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings FDA UDI
Identifiers
- Catalog Number
- 3.900863 FDA UDI
- Primary DI / UDI-DI
- 07613365002867 EUDAMEDFDA UDI
- Basic UDI-DI
- 76133650000000095C EUDAMED
- 510(k) Number
- K170182 FDA UDI
- FDA Product Code
- DPS FDA UDI
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2340 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
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
Cardiovit Ft-1 by Schiller AG — 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 | 76133650000000095C | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Schiller Ag
- EUDAMED SRN
- CH-MF-000012722
- Authorised Representative
- SCHILLER Medizintechnik GmbH DE-AR-000006934
Sources (2)
- EUDAMED 7f1a5ad9-7ecd-4279-95d3-b8e0bf266c10 61 fields · synced Aug 4, 2026
- FDA UDI f9d5e9a6-4ff0-4c5a-8388-40beab404351 37 fields · synced May 29, 2026