Organization name

Pacific Hospital Supply Co., Ltd.

SRN

TW-MF-000007247

Manufacturer status

Active

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

• "This product is for SINGLE USE ONLY. Discard after one procedure. Re-use of product may cause unpredicted health risk due to used product can be a potential carrier of pathogens,disseminating the infectious matters within the health care facilities. To re-process the used products arise more safety concerns regarding the cleanliness, sterility assurance level of certain processes."

  OTHER

Primary placement in Germany; available across 32 countries total.

Trade name

Disposable Syringe (Kit)

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.

04719879052039

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.

B-04719879052039

Reference / catalog number

TM0539N

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

MDD [Directive 93/42/EEC 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

• 100mL

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

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

• A02010401SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.