Organization name

Honeywell Healthcare Solutions GmbH

SRN

DE-MF-000004924

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Contains hazardous substances

  Kaliumhydroxid, Blei

Primary placement in Germany; available across 32 countries total.

Trade name

OOM101 MAX

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04036616011334

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

4036616OOMCK

Reference / catalog number

E1002659

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Sauerstoffsensor

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• R9080RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.