EUDAMED last updated this device on Aug 19, 2026

Once-Fil Flow

880951834TP02NE

On the marketClass IIa

Applicable legislation: —
Organization name: MEDICLUS 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 →: 08809518345663
Reference / catalog number: #101-1, #104-1, #101-2, #104-2, #104-3

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.

Once-Fil Flow is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by MEDICLUS Co., Ltd.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Once-Fil Flow
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 →: 08809518345663
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 →: 880951834TP02NE
Reference / catalog number: #101-1, #104-1, #101-2, #104-2, #104-3
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 IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 5
Additional product description: Once-Fil Flow is a temporary filling material with excellent flowability, elastic force and strength for effective margin sealing. It can be removed in one piece and can endure strong masticatory forces. It also provides excellent micro-space sealing ability.
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

UDI-DI DataMatrix

Encoded

(01)08809518345663

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.

Q01010199DENTAL RESTORATION DEVICES - OTHER

Critical warnings

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

1. Do not use One-Temp Flow in a patients with an allergy to resin. 2. Reuse of the enclosed tip may cause cross-infection, so the reuse of the tip is prohibited.
OTHER

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Türkiye; available across 1 country total.

Country	On market since	Until
TürkiyePrimary placement	May 19, 2022	Still on market

Once-Fil Flow

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

Related searches

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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Market distribution

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Manufacturer information

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Certificates covering this device

Certificates