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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

Zylomer Baby 50 — Class IIa MDR by NEOMEDIS

MD Atlas
NEOMEDIS

EUDAMED last updated this device on Jul 16, 2025

Zylomer Baby 50

3760436853760426850098J6

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NEOMEDIS
UDI-DI code: 03760426850098
Reference / catalog number: 11011FR

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Manufacturer information

Organization name: NEOMEDIS
SRN: FR-MF-000004432
Manufacturer status: Active

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Market distribution

Primary placement in France; available across 3 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Spain		Still on market
Italy		Still on market

Device identification

Trade name: Zylomer Baby 50
UDI-DI code: 03760426850098
Basic UDI-DI: 3760436853760426850098J6
Reference / catalog number: 11011FR
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: hygiene and hydration of the nasal mucosa and decongestion of the nose and nasal passageways while alleviating nasal symptoms associated with infections and allergies
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

Certificates

Certificate health across this manufacturer's portfolio.

146/MDRIssued
Quality assuranceNotified body: 0051Expiry: Mar 14, 2029