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EUDAMED last updated this device on Jun 9, 2026
B-06974084094283French Pharma Saline Solution 500ML is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by Longbow First Aid Products Co.,Ltd.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974084094283LBEWS500-2CN-MF-000032024G2S 060834 0022(01)06974084094283
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 France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q030103NASAL IRRIGATION SOLUTIONSPrimary 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 certificate specifically references this device's Basic UDI-DI.
697408409M04040301LBHDRVOn the marketFRANCE NEIR Burn Dressing 40x60cm697408409M04040301LBHDRVOn the marketFrench Pharma Saline Solution 1LB-06974084095136On the marketGauze compresses697408409M0202010101GCCVOn the marketHANS Burn dressing 10x10cm697408409M04040301LBHDRVOn the marketHANS Burngel3.5g697408409M04040301LBHG1BUOn 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.