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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

6000000199 — Class IIb MDD by IBSA Pharma SAS

MD Atlas
IBSA Pharma SAS

EUDAMED last updated this device on Aug 2, 2023

6000000199

B-03700640501581

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: IBSA Pharma SAS
UDI-DI code: 03700640501581
Reference / catalog number: 6000000199

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Manufacturer information

Organization name: IBSA Pharma SAS
SRN: FR-MF-000001187
Manufacturer status: Active

Critical warnings

8 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW277
EUDAMED did not publish a description for this code.
CW999
Do not swallow
CW999
Must not be used in case of known hypersensitivity to hyaluronic acid or one or more of the other components
CW999
Keep out of reach of children
CW275
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Mar 11, 2005	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03700640501581
Basic UDI-DI: B-03700640501581
Reference / catalog number: 6000000199
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M04041503DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

ialuset (crème)B-03700640501598On the market ialuset (crème)B-03700640501604On the market

Certificates

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.