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EUDAMED last updated this device on Mar 6, 2026
B-06223004250224ULTRAMED BLOOD ADMINISTRATION SET is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E). Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
062230042502247007(01)06223004250224
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z121799BLOOD TRANSFUSION INSTRUMENTS - OTHER6 warnings recorded — scroll inside the panel to see all entries.
1-Close completely flow control clamp. 2-Remove spike protector and insert full lenght of spike into the container. 3- Suspend container & fill the drip chamber half full with blood by squeezing and releasing. 4-Remove the needle protector. Open the flow control clamp gradually allowing the blood to displace air entirely in tubing and needle .Then close clamp tightly. 5-Perform vein puncture & regulate the flow rate by opening the clamp gradually.
• Do not use if the package is damaged. • For single use only. • Use Only With Blood or Blood Component Transfusion. • Discard after single use. • Storage at room Temperature (Upper limit of temperature =30℃ ± 2℃) • Storage up to Humidity (RH=65% (± 5) • For Short Term Use.
EG-MF-0000385621421C05201201Primary placement in Romania; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | Jan 1, 2020 | Dec 31, 2029 |
| Poland | Jan 1, 2020 | Dec 31, 2029 |
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 →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-06223004254130On the marketULTRAMED A.V. FISTULA NEEDLE 17 G (Single)622300425AVF9003RQOn the marketULTRAMED A.V. FISTULA NEEDLE 17 G (Single)B-06223004250385On the marketULTRAMED BLOOD ADMINISTRATION SET WITH LATEX622300425BTS7007VQOn the marketUltramed Burette Set measured volume fluid administration set - 100 ml622300425BUS1016UUOn the marketUltramed Burette Set measured volume fluid administration set - 150 ml622300425BUS1016UUOn the marketNo certificate specifically references this device's Basic UDI-DI.