EUDAMED last updated this device on Feb 3, 2026

API® NaCl 0.85% Medium

357302BUDI000213SV

On the marketIVDR Class A

Applicable legislation: —
Organization name: bioMérieux SA
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 →: 03573026588519
Reference / catalog number: 541047

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

API® NaCl 0.85% Medium is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by bioMérieux SA. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: API® NaCl 0.85% Medium
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 →: 03573026588519
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 →: 357302BUDI000213SV
Reference / catalog number: 541047
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 →: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: NaCl 0.85 % Medium and Suspension Medium are designed to be used as suspension media with API ®, ID 32 or ATB™ products.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Packaging levels

1 packaging level registered — each level carries its own UDI-DI.

03573026588519× 1 unitBase unit
- 03573026048129× 100 units

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03573026588519

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0104080299MANUAL IDENTIFICATION - OTHER

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in France; available across 30 countries total.

Country	On market since	Until
FrancePrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Iceland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market

Related searches

IVDR Class A medical devices in EUDAMED

Device identification

Trade name: API® NaCl 0.85% Medium
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 →: 03573026588519
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 →: 357302BUDI000213SV
Reference / catalog number: 541047
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 →: GS1

Device details

Quantity: 1
Additional product description: NaCl 0.85 % Medium and Suspension Medium are designed to be used as suspension media with API ®, ID 32 or ATB™ products.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

40536Supplemented
Quality management system
Notified 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.
: GMED SAS (0459)Expiry: Apr 5, 2027
40537Issued
Technical documentation
Notified 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.
: GMED SAS (0459)Expiry: Jun 14, 2031

Market distribution

Primary placement in France; available across 30 countries total.

Country	On market since	Until
FrancePrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Iceland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market

API® NaCl 0.85% Medium

Device identification

Classification

Device details

Packaging levels

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Packaging levels

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Certificates covering this device

Related devices