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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

161762 — Class IIa MDR by Orion Oyj

MD Atlas
Orion Oyj

EUDAMED last updated this device on Mar 21, 2025

161762

643210OIL001UB

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orion Oyj
UDI-DI code: 06432100102164
Reference / catalog number: 161762

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Manufacturer information

Organization name: Orion Oyj
SRN: FI-MF-000001595
Manufacturer status: Active

Critical warnings

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

CW135
EUDAMED did not publish a description for this code.
CW999
Do not use if the ear is inflamed or sore, the ear is secreting, the eardrum is injured, perforated or has been punctured (e.g. an ear tube), you are allergic (hypersensitive) to any of the ingredients in Remo-Wax Oil

Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Apr 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06432100102164
Basic UDI-DI: 643210OIL001UB
Reference / catalog number: 161762
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Remo-Wax Oil ear spray is an ear cure oil intended to be administered into the external ear canal in to order to prevent the cerumen impaction, to moisturize skin in the ear canal and to reduce the itching and irritation caused by the ear canal dryness.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q030499OTOLOGY DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

141482643210REM001UDOn the market 112170643210HUM001VTOn the market 161656643210REM001UDOn the market 112116643210REM001UDOn the market 142904643210OIL001UBOn the market

Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1230-861-24Supplemented
Quality management systemNotified body: 0537Expiry: Dec 22, 2028