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Organization name
UDI-DI code
Reference / catalog number

OH1758100 — Class IIa MDR by Laboratoire de la Mer

MD Atlas
Laboratoire de la Mer

EUDAMED last updated this device on May 13, 2026

OH1758100

356430LABMER-004/A-H6

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laboratoire de la Mer
UDI-DI code: 03595890243585
Reference / catalog number: OH1758100

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Manufacturer information

Organization name: Laboratoire de la Mer
SRN: FR-MF-000009050
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
WARNING : Protect from sunlight. Pressurized container : May burst if heated. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Do not pierce or burn, even after use. Do not expose to temperature exceeding 50°C/122°F. Do not spray on an open flame or other ignition source - Dot use the product in case of allergy to any of the ingredients. - Do not use the product in case of asthma. - Do not use the product in a child below 6 years of age. - Do not use the product during pregnancy or while breastfeeding.

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: not provided
UDI-DI code: 03595890243585
Basic UDI-DI: 356430LABMER-004/A-H6
Reference / catalog number: OH1758100
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)

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

LABMER-001/A-15B-03564300001015On the market OH1022030/OH2148030B-03564300001008On the market OH21132020B-08710537044546On the market ProrhinelB-05054563909336On the market OH2411100356430LABMER-002/C-GWOn 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.