EUDAMED last updated this device on May 30, 2026

12113

697461717ABGFSJN

On the marketClass IIa

Applicable legislation: —
Organization name: Hubei MeterOmega Technology LTD
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06974617172501
Reference / catalog number: 12113

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

12113 is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Hubei MeterOmega Technology LTD. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: not provided
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06974617172501
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. View in glossary →: 697461717ABGFSJN
Reference / catalog number: 12113
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Packaging levels

1 packaging level registered — each level carries its own UDI-DI.

06974617172501× 1 unitBase unit
- 16974617172508× 100 units

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06974617172501

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

A02010502BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Ireland; available across 2 countries total.

Country	On market since	Until
IrelandPrimary placement	Nov 28, 2025	Dec 31, 2029
Portugal	Mar 1, 2026	Dec 31, 2029

12113

Device identification

Classification

Device details

Packaging levels

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Packaging levels

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices

Certificates covering this device