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EUDAMED last updated this device on Jun 2, 2026
B-08964004839849Surgical Suction Cannula Needle is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Concise Enterprises. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
PK-MF-000034913PK21/818842665(01)08964004839849
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OTHER
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 Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Jan 1, 2014 | Jun 4, 2026 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08964004839849Basic 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-0896400483984930-01310-10ALUDI 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.
A010502EYE IRRIGATION NEEDLESPrimary 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-08964004839887On the marketOperating Surgical Scissor Straight S/BB-08964004839870On the marketReusable Surgical Tweezer 11cm, Non-SterileB-08964004839894On the marketSurgical Suction Cannula needle,Single Use, non sterileB-G20230012854AL0On the marketUniversal Utility ScissorB-08964004839900On the marketNo 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.No certificate specifically references this device's Basic UDI-DI.