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EUDAMED last updated this device on Apr 27, 2026
B-06974008076388A.V. Fistula Needle Sets For Single Use is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Dalian Aohua Medical Polymer Equipment Corporation. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CN-MF-000000794DD 60147772 0001(01)06974008076388
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 Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | 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.
06974008076388Basic 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-0697400807638817G×1″HTC-S30RUDI 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.
A010401ARTERIOVENOUS FISTULA 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 →No 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.B-06974008076074On the marketA.V. Fistula Needle Sets For Single UseB-06974008076470On the marketA.V. Fistula Needle Sets For Single UseB-06974008076142On the marketA.V. Fistula Needle Sets For Single UseB-06974008076395On the marketA.V. Fistula Needle Sets For Single UseB-06974008074810On the marketA.V. Fistula Needle Sets For Single UseB-06974008076173On the market