- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Sep 6, 2022
69213483FH0103R5LDisposable Endoscopic Linear Cutter Stapler is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Fengh Medical Co., Ltd.. Placed on the EU market in Northern Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06921348306644FH01(01)06921348306644
European Medical Device Nomenclature — the EU product classification assigned to this device.
H02030199LINEAR STAPLERS FOR VIDEOSURGERY - OTHER1 warning recorded — scroll inside the panel to see all entries.
1.Do not use the stapler on the central circulatory system. 2.Do not use the staplers on ischemic or necrotic tissue. 3.Do not use any linear cutter on major vessels without making provision for proximal and distal control. 4.Tissue thickness should be carefully evaluated before firing any stapler. Refer to Fengh Reference Table Reloads for tissue compression requirement (Open Staple Height) for each staple size. If tissue cannot comfortably compress to the closed staple height, or easily compress to less than the closed staple height, the tissue is contraindicated as it may be too thick or too thin for the selected staple size. 5.These staplers are not intended for use when surgical stapling is contraindicated.
CN-MF-000004718The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in XI; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| XIPrimary placement | Feb 14, 2023 | Dec 31, 2099 |
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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
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 →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 →69213483FH0102E4POn the marketDisposable Endoscopic Linear Cutter Stapler69213483FH0103E4SOn the marketDisposable Endoscopic Linear Cutter Stapler69213483FH0102E4POn the marketDisposable Endoscopic Specimen Retrieval Bags69213483FH0301E52On the marketDisposable Endoscopic Specimen Retrieval Bags69213483FH0301E52On the marketDisposable Endoscopic Specimen Retrieval Bags69213483FH0301E52On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
HZ 2082323-1AmendedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →