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SpO2 Adapter large, 3/Box

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 5010013

by MIPM Mammendorfer Institut für Physik und Medizin GmbH

Identity

Trade Name
SpO2 Adapter large, 3/Box EUDAMED
SpO2 Adapter, large, 3/Box FDA UDI
Generic Name
Pulse Co-oximeter probe, reusable FDA UDI
Device Name
Sp02 Adapter EUDAMED
Model / Reference
5010013 EUDAMED
SpO2 Adapter, large, 3/Box FDA UDI

Identifiers

Catalog Number
5010013 FDA UDI
Primary DI / UDI-DI
04255629200607 EUDAMEDFDA UDI
Basic UDI-DI
42556292001030LW EUDAMED
Unit of Use DI
04255629200898 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 EUDAMED
Class 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
MRI Safety
MR Conditional FDA UDI

SpO2 Adapter large, 3/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

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Manufacturer

Manufacturer
MIPM Mammendorfer Institut für Physik und Medizin GmbH
EUDAMED SRN
DE-MF-000007654

Sources (2)

  • EUDAMED 7f5fd0a2-f9bd-44e1-9bf1-38807d649d4e 61 fields · synced Oct 6, 2026
  • FDA UDI 016b94f9-a606-45d6-94a3-f46f39da4717 35 fields · synced May 30, 2026