Identity
- Trade Name
- SpO2 Clip Adapter EUDAMEDFDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- SpO2 Clip Adapter EUDAMED
- Model / Reference
- 5010103 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 5010103 FDA UDI
- Primary DI / UDI-DI
- 04255629200386 EUDAMEDFDA UDIEMIP50101031 FDA UDI
- Basic UDI-DI
- 42556292001015M2 EUDAMED
- Direct Marketing DI
- 04255629200379 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 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
Category: Pulse oximeter probe, reusable
SpO2 Clip Adapter by MIPM Mammendorfer Institut für Physik und Medizin GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Pulse oximeter probe, reusable.
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Cleared under the same submission
K142032 also covers:
- CO2 Adult Nasal Line — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- CO2 Airway Adapter — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- CO2 Monitoring Line M/M — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- CO2 Water Trap — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Fiber Optic Temperature Sensor Core — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Fiber Optic Temperature Sensor Core — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Fiber Optic Temperature Sensor Surface — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Gas Sample Line Set — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Gating Cable - Siemens — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IBP Interface cable (BD/Ohmeda - Argon Medical) — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IBP Interface cable (BD/Ohmeda - Argon Medical) — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IBP Interface cable (Edwards / Baxter - Edwards Lifesciences) — MIPM Mammendorfer Institut für Physik und Medizin GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (3)
- FDA UDI 2d1653b8-d9de-48a2-932a-cd75ac7112c5 35 fields · synced Oct 6, 2026
- FDA UDI cbcb5a55-402e-44f1-bd35-bdf561170a07 35 fields · synced May 30, 2026
- EUDAMED 9e10b17b-3a53-4bd8-ae15-3d20c79df00e 61 fields · synced Jul 24, 2026