Organization name

Hospital & Homecare Medical Device Co., Ltd. China

SRN

CN-MF-000032014

Manufacturer status

Active

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

• ① Acute urethritis ② Acute prostatitis ③ Acute epididymitis

  OTHER

Primary placement in Austria; available across 32 countries total.

Trade name

not provided

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.

06975883473118

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.

697588347HK01bRD

Reference / catalog number

HK01b24

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The product is made of pure silicone and does not incorporate medicinal substance, animal tissues, or blood components. The shelf-life is 5 years. The product is available in two types, two-way Silicone Foley Catheter and three-way Silicone Foley Catheter. The two-way type is composed of a double lumen shaft, a tip, a retention balloon, a drainage funnel, an inflation access port with valve. The three-way type is composed of a triple lumen shaft, a tip, a retention balloon, a drainage funnel, an inflation access port with valve and irrigation access port. The product is single use only and belongs to invasive devices with respect to body orifices (into the vesical cavity through the urethra). The continuous use for a single device is for no more than 29 days. The cumulative use for each type of urethral catheter can exceed 30 days. It is provided in sterile status and is sterilized by Ethylene Oxide (EO).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• 06975883473118× 1 unitBase unit
  • 16975883473115× 10 units
    • 26975883473112× 25 units

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

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

• U010299URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.