Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

OC01B - Hypertonic solution — Class IIa MDD by S.I.I.T. srl

MD Atlas
S.I.I.T. srl

EUDAMED last updated this device on May 25, 2026

OC01B - Hypertonic solution

B-060084907T

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: S.I.I.T. srl
UDI-DI code: D-060084907T
Reference / catalog number: OC01B - Hypertonic solution

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?

View device family (Basic UDI)

Manufacturer information

Organization name: S.I.I.T. srl
SRN: IT-MF-000022188
Manufacturer status: Active

Critical warnings

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

CW010
.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-060084907T
Basic UDI-DI: B-060084907T
Reference / catalog number: OC01B - Hypertonic solution
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Spray nasale, utile nel trattamento di patologie respiratorie quali il raffreddore comune e la rinite, che possono evolvere in rinosinusite acuta o cronica e rinite allergica.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q030199NASOPHARYNGEAL DEVICES - OTHER

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

Become a partner of MD Atlas

Related devices

OC10A - Throat sprayB-060086147MOn the market OC05BB-060089478KOn the market BC21 (Bottle 30 mL)B-060075297NOn the market OC01A - Mild hypertonic solutionB-060062867COn the market OC01A - Mild hypertonic solutionB-060062877EOn the market

Certificates

Certificate health across this manufacturer's portfolio.

065-00-01-MDRSupplemented
Quality management systemNotified body: 0426Expiry: Nov 20, 2029