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CARDIOVIT CS-200 Excellence (ErgoSpiro)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3.920280Model CARDIOVIT CS-200 Excellence (ErgoSpiro)
by Schiller Ag
Identity
- Trade Name
- CARDIOVIT CS-200 Excellence (ErgoSpiro) EUDAMEDCARDIOVIT CS-200 Excellence FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- CARDIOVIT CS-200 Excellence (ErgoSpiro) EUDAMEDThe CARDIOVIT CS-200 Excellence is a multichannel ECG device used for the recording, analysis and evaluation of ECG recordings. It is designed for indoor use and can be used for all patients of both sexes, all races, and all ages and is intended for use in hospitals, cardiologic units, out-patient clinical units, and general physicians offices.The diagnostic applications for which the CARDIOVIT CS-200 Excellence is intended is in the field of cardiac abnormalities in the general population, detecting acute myocardial ischemia, and infarction in chest pain patients. FDA UDI
- Model / Reference
- CARDIOVIT CS-200 Excellence (ErgoSpiro) EUDAMED3.920280 EUDAMEDFDA UDI
- Description
- The CARDIOVIT CS-200 Excellence is a multichannel ECG device used for the recording, analysis and evaluation of ECG recordings. It is designed for indoor use and can be used for all patients of both sexes, all races, and all ages and is intended for use in hospitals, cardiologic units, out-patient clinical units, and general physicians offices.The diagnostic applications for which the CARDIOVIT CS-200 Excellence is intended is in the field of cardiac abnormalities in the general population, detecting acute myocardial ischemia, and infarction in chest pain patients. FDA UDI
Identifiers
- Catalog Number
- 3.920280 FDA UDI
- Primary DI / UDI-DI
- 07613365001105 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07613365001105 EUDAMED
- 510(k) Number
- K970879 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
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
MR Unsafe FDA UDI
CARDIOVIT CS-200 Excellence (ErgoSpiro) by Schiller AG — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07613365001105 | 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 64312544-ef1d-4000-bf84-caa348536af1 61 fields · synced Jul 10, 2026
- FDA UDI 16475727-a65b-4038-8b4a-a9162ed2b968 37 fields · synced May 30, 2026