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CN-MF-000013084HD 2039285-1PTZJ-D-26-195 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Zhuji Pengtian Medical Instrument Co.,Ltd. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 21, 2026
B-06950190431297Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06950190431297
1 warning recorded — scroll inside the panel to see all entries.
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.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Italy; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06950190431297Basic 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-06950190431297PTZJ-D-26-195UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
G030202DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPSNo certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.