Biliband Eye Protector

by Natus Medical Denmark ApS EUDAMEDGUDID

Active European Union and United States

Ref 900643Model Bilibands

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number5713315NA0002354 Basic UDI-DI	Date15 Oct 2025Registered	StatusActive
United States	GUDID listing GUDID	Number05713315011771 UDI-DI	Date14 Oct 2025Listed	StatusIn distribution

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name: Bilband
Generic Name: Eye mask
Device Name: Biliband Eye Protector
Model / Ref / Catalog: Bilibands, 900643
Description: Biliband Premature 24-33 cm

Primary DI / UDI-DI: 05713315011771
Basic UDI-DI: 5713315NA0002354
FDA Product Code: FOK
EMDN Code: V0201 Phototherapy masks
GMDN Term: Eye mask

Device Class: Class I
Regulation Number: 880.5270
Market of Registration: Denmark
Commercial Distribution: In Commercial Distribution

MRI Safety: MR Unsafe

Manufacturer details

EUDAMED SRN: DK-MF-000001617

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Properties

Single Use
Reprocessed
Prescription Use
Premarket Exempt
Lot / Batch Number
Expiration Date

Other properties (18)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Manufacturing Date: No