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Organization name
UDI-DI code
Reference / catalog number

161656 — Class IIa MDR by Orion Oyj

MD Atlas
Orion Oyj

EUDAMED last updated this device on Apr 5, 2024

161656

643210REM001UD

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orion Oyj
UDI-DI code: 06432100102119
Reference / catalog number: 161656

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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 Remo Wax 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). Do not use Remo-Wax if you are allergic (hypersensitive) to any of the ingredients of Remo-Wax.

Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	May 20, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06432100102119
Basic UDI-DI: 643210REM001UD
Reference / catalog number: 161656
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 solution is a yellowish, clear or opalescent liquid intended to be used as ear drops or ear spray and it is applied in the ear in order to dissolve impacted ear wax. After using Remo-Wax, the ear canal must be irrigated with water by using ear pump (bulb syringe) or user may visit a health care professional for ear irrigation
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 112116643210REM001UDOn the market 161762643210OIL001UBOn 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