Identity
- Trade Name
- SpO2 Adapter small, 10/Box EUDAMEDSpO2 Adapter, small, 10/box FDA UDI
- Generic Name
- Pulse Co-oximeter probe, reusable FDA UDI
- Device Name
- Sp02 Adapter EUDAMED
- Model / Reference
- 5010024 EUDAMEDSpO2 Adapter, small, 10/box FDA UDI
Identifiers
- Catalog Number
- 5010024 FDA UDI
- Primary DI / UDI-DI
- 04255629200577 EUDAMEDFDA UDI
- Basic UDI-DI
- 42556292001030LW EUDAMED
- Unit of Use DI
- 04255629200874 EUDAMED
- 510(k) Number
- K142032 FDA UDI
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Pulse Co-oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Market of Registration
- Germany 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
SpO2 Adapter small, 10/Box by MIPM Mammendorfer Institut für Physik und Medizin GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 42556292001030LW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- DE-MF-000007654
Sources (2)
- EUDAMED 287b5b07-093f-4a7b-8748-2431369adbf4 61 fields · synced May 30, 2026
- FDA UDI 1a7e870b-96a7-4a7b-b256-97a78ed048cd 35 fields · synced May 30, 2026