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.Must be operated by a trained physician. 2.The packaging of the stone basket is damaged, it is strictly prohibited to use. 3.Stone basket beyond the validity period, strictly prohibited use. 4.Disposable use, destroy after use, reuse is strictly prohibited. 5.Extra care should be taken when removing foreign bodies from the digestive tract to avoid blocking the respiratory tract. 6.The injection of contrast media during ERCP surgery must be carried out under X-ray supervision. 7.The stone basket is a disposable product, one for each patient, and shall not be used cross-over between patients.

Primary placement in Türkiye; 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.

06950190423391

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-06950190423391

Reference / catalog number

PTQ-1818-20-A

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.

• G0305010202DIGESTIVE ENDOSCOPY, RETRIEVAL BASKET DEVICES, NON-REVOLVING

• Class IIa medical devices in EUDAMED

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