EUDAMED last updated this device on Jun 16, 2026

TopFine®

B-08809445831833

On the marketClass IIa

Applicable legislation: —
Organization name: Medexel 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 →: 08809445831833
Reference / catalog number: 31G(0.25mm) x 4mm

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.

TopFine® is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Medexel Co.,Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: TopFine®
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 →: 08809445831833
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 →: B-08809445831833
Reference / catalog number: 31G(0.25mm) x 4mm
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: 1
Additional product description: Insulin Pen Needles are single use, sterile, medical devices designed to be used in conjunction withpen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health careprofessionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths(4mm, 5mm, 6mm, 8mm, 12mm, and 12.7mm). Insulin Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Insulin Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper.
Additional information URL: https://medexel.co.kr/en/
Clinical sizes: 0.254–0.267 MU50
2.75–5.25 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08809445831833

EMDN nomenclature code(s)

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

A0101010202HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

Do not re-use
This product is a single-use device
Do not resterilize
This product is provided sterile
Do not use if package is damaged
This product is a sterile device
Do not use past indicated date
This product has 5 years shelf-life

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 4 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Bulgaria	—	Still on market
EL	—	Still on market
Croatia	—	Still on market

TopFine®

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UDI-DI DataMatrix

EMDN nomenclature code(s)

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Regulatory

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Market distribution

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Device identification

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Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Legacy certificates

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Legacy certificates

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