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Organization name
UDI-DI code
Reference / catalog number

Babysoin — Class IIb MDR by UNITHER INDUSTRIES

MD Atlas
UNITHER INDUSTRIES

EUDAMED last updated this device on Jul 11, 2025

Babysoin

361563Saline0.9%UR

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: UNITHER INDUSTRIES
UDI-DI code: 03701510100231
Reference / catalog number: 3701510100231

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Manufacturer information

Organization name: UNITHER INDUSTRIES
SRN: FR-MF-000027437
Manufacturer status: Active

Critical warnings

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

CW275
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
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.
CW135
EUDAMED did not publish a description for this code.
CW999
Contraindicated in case of hypersensitivity to any of the components. Do not use on injured eyes or nose. Do not use the same single-dose vial for different uses or people. If any side-effect occurs, consult a healthcare professional. In case of deterioration of health or if no improvement is noted, consult a healthcare professional.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Aug 1, 2025	Still on market

Device identification

Trade name: Babysoin
UDI-DI code: 03701510100231
Basic UDI-DI: 361563Saline0.9%UR
Reference / catalog number: 3701510100231
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Sterile solution containing 0.9% of sodium chloride. Box of 20 single-dose vials of 5mL.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02030299OPHTHALMOLOGY, LIQUID FLUIDS - OTHER
Q030103NASAL IRRIGATION SOLUTIONS

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

BABY LOOK361563Saline0.9%UROn the market Sérum physiologique Arrow361563Saline0.9%UROn the market Sérum physiologique Cooper361563Saline0.9%UROn the market 3701510100224361563Saline0.9%UROn the market Sérum physiologique Cooper361563Saline0.9%UROn 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.