EUDAMED last updated this device on Jun 8, 2026

Sterile adhesive eye cover

69380562EY002N3

On the marketClass I

Applicable legislation: —
Organization name: Zhejiang Hongyu Medical Commodity Co.,Ltd
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06938056233810
Reference / catalog number: BLK-4-

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Sterile adhesive eye cover is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Zhejiang Hongyu Medical Commodity Co.,Ltd. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Sterile adhesive eye cover
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06938056233810
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 69380562EY002N3
Reference / catalog number: BLK-4-
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 100
Additional product description: Sterile adhesive eye cover intended to protect and keep the patient's eyelids closed during surgical and medical procedures. The product provides a breathable and water-resistant barrier that helps reduce the risk of corneal abrasion, contamination, and accidental eye exposure during anesthesia or surgery. The anatomically shaped design ensures a comfortable fit around the eye area. The hypoallergenic adhesive allows gentle fixation and atraumatic removal, minimizing the risk of skin irritation, eyelash removal, or medical adhesive-related skin injury (MARSI). The product is single-use, latex-free, and suitable for adult or pediatric patients depending on the model.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 65mm×28mm

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06938056233810

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

M04010299FIXING DRESSINGS - OTHER

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	—	Still on market

Sterile adhesive eye cover

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

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Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

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