Identity
- Trade Name
- Sensor Pads EUDAMEDSensor Pad FDA UDI
- Generic Name
- Hypoallergenic skin adhesive tape FDA UDI
- Device Name
- Sensor Pads EUDAMEDSensor Pads are intended for use with Lucerno Dynamics sensors on clean, dry, intact skin. The sensor side adhesive is not intended for skin contact. Factors that may impact pad performance include lotion or other skin products, patient movement, and substantial body hair. Sensor Pads consist of a double-coated, two-in-one medical grade silicone adhesive and acrylic tape. The silicone adhesive is hypoallergenic and atraumatic upon removal; it is intended for attachment to the skin. The acrylic tape is intended for attachment to the plastic case of the sensor. FDA UDI
- Model / Reference
- 091220-018 EUDAMEDFDA UDI
- Description
- Sensor Pads are intended for use with Lucerno Dynamics sensors on clean, dry, intact skin. The sensor side adhesive is not intended for skin contact. Factors that may impact pad performance include lotion or other skin products, patient movement, and substantial body hair. Sensor Pads consist of a double-coated, two-in-one medical grade silicone adhesive and acrylic tape. The silicone adhesive is hypoallergenic and atraumatic upon removal; it is intended for attachment to the skin. The acrylic tape is intended for attachment to the plastic case of the sensor. FDA UDI
Identifiers
- Catalog Number
- 091220-018 FDA UDI
- Primary DI / UDI-DI
- 00850014578145 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850014578SensorPads26 EUDAMED
- Unit of Use DI
- 00850014578138 EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.) EUDAMED
- GMDN Term
- Hypoallergenic skin adhesive tape FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Norway 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sensor Pads by Lucerno Dynamics, LLC — 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 | 0850014578SensorPads26 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Lucerno Dynamics, LLC
- EUDAMED SRN
- US-MF-000001351
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 099eb206-a27c-404f-98f1-898759ff2020 61 fields · synced Jul 14, 2026
- FDA UDI da515c18-0998-47b9-a5a9-3497916912ae 36 fields · synced May 30, 2026