Organization name

Zhuji Pengtian Medical Instrument Co.,Ltd

SRN

CN-MF-000013084

Manufacturer status

Active

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

• CW011

  1. It must be performed by a trained physician. 2. The disposable hemoclips device is compatible with endoscopes with a working channels equal to or greater than 2.8mm. 3. The disposable hemoclips is disposable product and should not be used interchangeably between patients. 4. The disposable hemoclips has been sterilized and check the device carefully before use. Make sure the product or sterile packaging is not damaged during shipping. Do not use if damaged. Please return the damaged product to the manufacturer immediately. 5. If tangential pressure is applied to open or closed hemoclips, it may cause the hemoclips to separate from the pusher, twist, or damage the device. 6. Do not use the hemoclips if it is twisted or damaged during insertion or movement of the device. Please call the manufacturer and return the product. 7. If the position of the endoscope is special, it may be necessary to slightly relax the endoscope to allow the device to move forward, and then reposition the endoscope for treatment. 8. Do not use if the product beyond the expiration date, and advised to negotiate with the manufacturer 9. During operation, if the hemoclips cannot be detached from the device or other accidents occur, timely surgical operation can be performed as an emergency measure. 10. Used products should be disposed of in accordance with relevant national regulations on waste treatment.

Primary placement in Italy; 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.

06950190431198

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-06950190431198

Reference / catalog number

PTZJ-D-26-190

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

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.

• G030202DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS

• Class IIa medical devices in EUDAMED

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