Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Zylomer Baby — Class IIa MDR by NEOMEDIS

MD Atlas
NEOMEDIS

EUDAMED last updated this device on Jun 4, 2025

Zylomer Baby

3760436853760426850067HT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NEOMEDIS
UDI-DI code: 03760426850067
Reference / catalog number: 11011FR

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

Hypomer baby3760436853760426850210H8On the market Hypomer baby3760436853760426850227HROn the market Hypomer baby3760436853760426850234HNOn the market Hypomer fresh3760436853760426850142HGOn the market Hypomer fresh3760426837604268502654ROn the market

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jan 1, 2025	Still on market

Device identification

Trade name: Zylomer Baby
UDI-DI code: 03760426850067
Basic UDI-DI: 3760436853760426850067HT
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