Organization name

pro3dure medical GmbH

SRN

DE-MF-000000024

Manufacturer status

Active

EPRCA1000331

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.

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

• GHS07 - Warning -Toxic cat. 4, Irritant cat. 2 or 3, Lower systemic health hazards
• GHS08 - Danger or Warning - Systemic health hazards
• H317 – May cause an allergic skin reaction.
• H360 – May damage fertility or the unborn child.
• P201 – Obtain special instructions before use.
• P202 – Do not handle until all safety precautions have been read and understood.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P263 – Avoid contact during pregnancy/while nursing.
• P264 – Wash thoroughly after handling.
• P272 – Contaminated work clothing should not be allowed out of the workplace.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P302 – IF ON SKIN: P352 – Wash with plenty of soap and water.
• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.
• P308 – IF exposed or concerned: P313 – Get medical advice/attention.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• P306 – IF ON CLOTHING: P362 – Take off contaminated clothing and wash before reuse.
• P364 And wash it before reuse.
• P233 – Keep container tightly closed.
• Do not use if package is damaged
• Contains hazardous substances
• Consult instructions for use
• Shake well before use. [...] contraindicated... 1. ... If a patient is known to be allergic to any of the ingredients. 2. ... For every application that is not part of the indication.

  OTHER

Primary placement in Germany; available across 32 countries total.

Trade name

audioprint GR-1

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

EPRCA1000331

Basic UDI-DI

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.

++EPRC12140201BF

Reference / catalog number

A1000331

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

HIBCC

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 385–405 MU66
• tan-opaque
• 1000 MU24

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• Y214580HEARING AIDS OR HEARING DEVICES - ACCESSORIES

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.