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.The product must be operated by a trained physician. 2.The minimum compatible working channel of the device is 2.0mm. 3.The product is for single use only and should not be used across patients. 4.The product has been sterilized and check the device carefully before use. Make sure the product or sterile packaging is not twisted or damaged during shipping. Do not use if damaged. Please return the damaged product to the manufacturer immediately. 5.Check directly under the endoscope to determine whether the injection needle is positioned correctly. Injecting in an improper position or injecting too deeply may cause injury to the patient. 6.Must have a thorough understanding of the technical principles, clinical applications and related risks of endoscopic injection therapy before use. 7.If the position of the endoscope is special, it may be necessary to relax the endoscope slightly to allow the device to advance, and then reposition the endoscope for treatment. 8.The product cannot be used after the expiration date and advised to negotiate with the manufacturer.

Primary placement in Poland; 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.

06950190417376

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-06950190417376

Reference / catalog number

PTI-2323-2204-B

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.

• G03020101DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES

• Class IIa medical devices in EUDAMED

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