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Cardiovit At-180
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3.920570Model CARDIOVIT AT-180
by Schiller Ag
Identity
- Trade Name
- CARDIOVIT AT-180 EUDAMEDFDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- CARDIOVIT AT-180 EUDAMEDThe CARDIOVIT AT-180 is an electrocardiograph intended to be used by trained operators under the direct supervision of a licensed physician in healthcare facilities to acquire ECG signals from body surface electrodes, record, analyse, display and print ECGs to support diagnosis of cardiovascular diseases in adult and paediatric patients at rest. FDA UDI
- Model / Reference
- CARDIOVIT AT-180 EUDAMED3.920570 EUDAMEDFDA UDI
- Description
- The CARDIOVIT AT-180 is an electrocardiograph intended to be used by trained operators under the direct supervision of a licensed physician in healthcare facilities to acquire ECG signals from body surface electrodes, record, analyse, display and print ECGs to support diagnosis of cardiovascular diseases in adult and paediatric patients at rest. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613365002775 EUDAMEDFDA UDI
- Basic UDI-DI
- 76133650000000085A EUDAMED
- Direct Marketing DI
- 07613365002775 EUDAMED
- 510(k) Number
- K183425 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
- Slovenia 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
MR Unsafe FDA UDI
Cardiovit At-180 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 | 76133650000000085A | 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 70403b42-0468-4f11-9985-5ce41daca775 61 fields · synced Jul 15, 2026
- FDA UDI 323e74bd-dee3-41c0-a749-f9ebc2e64f64 35 fields · synced May 30, 2026