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

5 400951 991160 — Class IIa MDD by Laboratoire Unither

MD Atlas
Laboratoire Unither

EUDAMED last updated this device on Nov 21, 2024

5 400951 991160

B-5400951991160XP

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Laboratoire Unither
UDI-DI code: D-5400951991160XP
Reference / catalog number: 5 400951 991160

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: Laboratoire Unither
SRN: FR-MF-000004062
Manufacturer status: Active

Related devices

5 902666 653086B-59026666530866QOn the market 8 470002 411531 B-8470002411531V2On the market 8 470001 939227B-8470001939227YSOn the market 8 480017 276193B-84800172761933ROn the market ALVITA®B-5055382314318W9On 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.

Market distribution

Primary placement in EL; available across 1 country total.

Country	On market since	Until
ELPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-5400951991160XP
Basic UDI-DI: B-5400951991160XP
Reference / catalog number: 5 400951 991160
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R060203INHALATION THERAPY HUMIDIFICATION LIQUIDS
V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Q03040299EAR IRRIGATION DEVICES - OTHER
Q030103NASAL IRRIGATION SOLUTIONS
Q02030299OPHTHALMOLOGY, LIQUID FLUIDS - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification