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Little PALS
EUDAMEDFDA UDIClass I (EU MDR)
Ref SEN 5001Model Sensing Electrodes
Identity
- Trade Name
- Little PALS EUDAMEDFDA UDI
- Generic Name
- Neonatal electrocardiographic electrode FDA UDI
- Device Name
- Sensing Electrodes EUDAMED
- Model / Reference
- Sensing Electrodes EUDAMEDSEN 5001 EUDAMEDSEN5001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851913006111 EUDAMEDFDA UDI
- Basic UDI-DI
- 00856817005Sens3D EUDAMED
- 510(k) Number
- K000206 FDA UDI
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501,N010201 EUDAMED
- GMDN Term
- Neonatal electrocardiographic electrode FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Denmark 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Little PALS by Axelgaard Manufacturing Co., Ltd. — 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 | 00856817005Sens3D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Axelgaard Manufacturing Co., Ltd.
- EUDAMED SRN
- US-MF-000009382
- Authorised Representative
- Axelgaard Manufacturing Co., Ltd. DK-AR-000002096
Sources (2)
- EUDAMED 372273e7-9cb7-45e4-a496-b9098ba89bf6 61 fields · synced May 30, 2026
- FDA UDI 38e79fb9-1220-47d8-9247-716c16228b7d 34 fields · synced May 30, 2026