Identity
- Trade Name
- Cardio7 FDA UDI
- Generic Name
- ST-segment electrocardiographic monitor FDA UDI
- Device Name
- Electrocardiographs & Spirometers EUDAMEDELECTROCARDIOGRAPH FDA UDI
- Model / Reference
- Cardio7 EUDAMEDFDA UDImany EUDAMED
- Description
- ELECTROCARDIOGRAPH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809276943552 EUDAMEDFDA UDI
- Basic UDI-DI
- 880927694C72C EUDAMED
- Direct Marketing DI
- 08809276943552 EUDAMED
- 510(k) Number
- K113306 FDA UDI
- FDA Product Code
- DPS FDA UDI
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
- GMDN Term
- ST-segment electrocardiographic monitor 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
No
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
Category: ST-segment electrocardiographic monitor
Cardio7 by Bionet Company, Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as ST-segment electrocardiographic monitor.
- CardioCare2000 — Bionet Company, Ltd. · Class II
- CardioXP — Bionet Company, Ltd. · Class II
- CardioTouch3000 — Bionet Company, Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bionet Company, Ltd.
Sources (2)
- FDA UDI 3095e23b-0093-4b94-95c8-7faaea58deab 34 fields · synced Jul 31, 2026
- EUDAMED 07371f33-9444-4903-a3b3-743f654d34ac 61 fields · synced Jul 31, 2026