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PalmSAT Charger
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 110286-001Model MODEL 2500C, PULSE OXIMETER CHARGER, INMETRO
Identity
- Trade Name
- PalmSAT Charger EUDAMEDHANDHELD PULSE OXIMETER FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- PalmSAT'Charger EUDAMEDHANDHELD PULSE OXIMETER with 2500C, PULSE OXIMETER CHARGER FDA UDI
- Model / Reference
- MODEL 2500C, PULSE OXIMETER CHARGER, INMETRO EUDAMED110286-001 EUDAMED2500C, PULSE OXIMETER CHARGER FDA UDI
- Description
- HANDHELD PULSE OXIMETER with 2500C, PULSE OXIMETER CHARGER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849686065855 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849686065855 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Netherlands 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
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
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
PalmSAT Charger by Nonin Medical, Inc. — Class IIb — 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-00849686065855 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Nonin Medical, Inc.
- EUDAMED SRN
- US-MF-000008228
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED cc1b0788-acf0-48be-917d-0252e8dfc416 61 fields · synced Oct 6, 2026
- FDA UDI 2e748c12-1d6d-4e3c-8107-30e9c6b71230 33 fields · synced May 30, 2026