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Organization name
UDI-DI code
Reference / catalog number

OCEAN BIO-ACTIF Ear hygiene — Class IIa MDR by YSLAB

MD Atlas
YSLAB

EUDAMED last updated this device on Jul 21, 2025

OCEAN BIO-ACTIF Ear hygiene

376013270BOVAU05B3

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: YSLAB
UDI-DI code: 03760132700694
Reference / catalog number: PF_3760132700694

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Manufacturer information

Organization name: YSLAB
SRN: FR-MF-000001197
Manufacturer status: Active

Critical warnings

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

CW268
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW157
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		Still on market

Device identification

Trade name: OCEAN BIO-ACTIF Ear hygiene
UDI-DI code: 03760132700694
Basic UDI-DI: 376013270BOVAU05B3
Reference / catalog number: PF_3760132700694
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 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)

Q03040299EAR IRRIGATION DEVICES - OTHER

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

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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.