Organization name

ASAHI INTECC CO., LTD.

SRN

JP-MF-000010199

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• Do not resterilize
• Do not re-use

Primary placement in Austria; available across 32 countries total.

Trade name

Fielder

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.

04547327141185

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.

4547327DGW002NZ

Reference / catalog number

AGP140200

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 III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 0.014 MU28
• 235 MU10

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

• 04547327141185× 1 unitBase unit
  • 14547327141182× 5 units

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

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

• C04010201CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.