Identity
- Trade Name
- VitalPatch Adhesive Overlay EUDAMEDFDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
- Device Name
- VitalPatch Adhesive Overlay EUDAMEDFDA UDI
- Model / Reference
- 3801-01 EUDAMEDFDA UDI
- Description
- VitalPatch Adhesive Overlay FDA UDI
Identifiers
- Catalog Number
- 3801-01 FDA UDI
- Primary DI / UDI-DI
- 00850490007283 EUDAMEDFDA UDI
- Basic UDI-DI
- 08504900071100HG EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- H900299 TAPES, MEDICAL/SURGICAL - OTHER EUDAMED
- GMDN Term
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 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
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
VitalPatch Adhesive Overlay by VitalConnect, Inc. — Class I — 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 | 08504900071100HG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VitalConnect, Inc.
- EUDAMED SRN
- US-MF-000010637
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 79071fa8-48e1-4dcc-a577-591878fe5f3f 61 fields · synced Jul 26, 2026
- FDA UDI af5d0f68-2bb7-454e-b9a2-100f2077bddc 34 fields · synced May 30, 2026