Identity
- Trade Name
- SMARTSIGNS EUDAMEDDOPPLEX FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- SC300 SPOT MONITOR EUDAMEDSMARTSIGNS MINIPULSE FDA UDI
- Model / Reference
- SC300 EUDAMEDMP1-UNIT EUDAMEDMP1 FDA UDI
- Description
- SMARTSIGNS MINIPULSE FDA UDI
Identifiers
- Catalog Number
- MP1-USA FDA UDI
- Primary DI / UDI-DI
- 05051968022240 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520372WF EUDAMED
- 510(k) Number
- K081572 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES 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
- Ireland 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
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Smartsigns by Arjohuntleigh AB — Class IIb — 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 | 5060693520372WF | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (2)
- EUDAMED 4a589fb0-85c4-4e01-ba02-d5b011f28267 61 fields · synced Sep 17, 2026
- FDA UDI 89aa5f5f-fd69-4fc7-8b9e-911c09f0d122 37 fields · synced May 30, 2026