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

Eye shield — Class I MDR by Hubert De Backer nv

MD Atlas
Hubert De Backer nv

EUDAMED last updated this device on Sep 18, 2023

Eye shield

5400995EyeShieldsHG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hubert De Backer nv
UDI-DI code: 05400995000057
Reference / catalog number: T2015/1

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: Hubert De Backer nv
SRN: BE-MF-000020418
Manufacturer status: Active

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: Eye shield
UDI-DI code: 05400995000057
Basic UDI-DI: 5400995EyeShieldsHG
Reference / catalog number: T2015/1
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1350
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)

Q0299OPHTHALMIC 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Cup5400995CupsCYOn the market V0091985400995DosingApplicatorSDOn the market V0005065400995Applicators76On the market V0001665400995Plugs-PIBAsDLOn the market

Certificates

Certificate health across this manufacturer's portfolio.

BE24/00000031Issued
Quality assuranceNotified body: 1639Expiry: Feb 9, 2029