- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Feb 15, 2025
B-06970057552286CITEC is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Changzhou Intl. Trade & Enterprises Cooperative Co.,Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06970057552286CIT-BH-01CN-MF-000010512HD 2057087-1(01)06970057552286
1 warning recorded — scroll inside the panel to see all entries.
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 8 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | May 1, 2015 | Dec 31, 2028 |
| Cyprus | May 1, 2015 | Dec 31, 2028 |
| Germany | May 1, 2021 | Dec 31, 2028 |
| Denmark | May 1, 2022 | Dec 31, 2028 |
| EL | May 1, 2021 | Dec 31, 2028 |
| Spain | May 1, 2019 | Dec 31, 2028 |
| Finland | May 1, 2021 | Dec 31, 2028 |
| Latvia | May 1, 2021 | Dec 31, 2028 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
K0201010602LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, SINGLE-USEPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →B-06970057551265On the marketBiopsy ForcepB-06975238201977On the marketBronchial StentB-06970057551579On the marketClean Cap avec connexion à CO2B-06975238204336On the marketClean Cap avec connexion à CO2 à 1,1 mètreB-06975238204343On the marketClean Cap sans connexion à CO2B-06975238204350On the marketNo 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.