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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

3701510100224 — Class IIb MDR by UNITHER INDUSTRIES

MD Atlas
UNITHER INDUSTRIES

EUDAMED last updated this device on May 19, 2025

3701510100224

361563Saline0.9%UR

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: UNITHER INDUSTRIES
UDI-DI code: 03701510100224
Reference / catalog number: 3701510100224

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Manufacturer information

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

Critical warnings

10 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.
CW999
Do not use on injured eyes or nose.
CW999
Do not use the same single-dose vial for different uses or people.
CW999
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	Jul 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03701510100224
Basic UDI-DI: 361563Saline0.9%UR
Reference / catalog number: 3701510100224
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 40 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

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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.