Identity
- Trade Name
- VitalPatch EUDAMEDVitalPatch 2.0 FDA UDI
- Generic Name
- Electrocardiography telemetric monitoring system FDA UDI
- Device Name
- VitalPatch EUDAMEDVitalPatch 2.0, 7 days FDA UDI
- Model / Reference
- 3037-01 EUDAMEDFDA UDI
- Description
- VitalPatch 2.0, 7 days FDA UDI
Identifiers
- Catalog Number
- 3037-01 FDA UDI
- Primary DI / UDI-DI
- 00850490007238 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850490007238 EUDAMED
- 510(k) Number
- K190916 FDA UDI
- FDA Product Code
- DRG FDA UDIDSI FDA UDIMHX FDA UDI
- EMDN Code
- Z12050803 ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS EUDAMED
- GMDN Term
- Electrocardiography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2910 FDA UDI870.1025 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
VitalPatch by VitalConnect, Inc. — 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-00850490007238 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- VitalConnect, Inc.
- EUDAMED SRN
- US-MF-000010637
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 02a34c2f-898f-4ec5-bc0a-e95dbcc49a63 61 fields · synced Jul 9, 2026
- FDA UDI 63d57c45-814e-4674-bf48-827a3f9db363 35 fields · synced May 30, 2026