Organization name

Sentec AG

SRN

CH-MF-000008058

Manufacturer status

Active

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

• H317 – May cause an allergic skin reaction.

  It is not recommended to use sensor attachment accessories on patients who exhibit allergic reactions to adhesive tapes.

Primary placement in Germany; available across 28 countries total.

Trade name

Multi-Site Attachment Ring

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.

07640121880797

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.

764012188MARJD

Reference / catalog number

MARe-MI

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Single use sensor application ring, recommended for adult, pediatric and neonatal patients with mature/intact skin

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.

• Z1203020405TRANSCUTANEOUS PO2/PCO2 MONITORS

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.