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Organization name
UDI-DI code
Reference / catalog number

07011593 — Class IIa MDR by Oystershell NV

MD Atlas
Oystershell NV

EUDAMED last updated this device on May 21, 2025

07011593

5410765SolverRT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oystershell NV
UDI-DI code: 05410765006318
Reference / catalog number: 07011593

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Manufacturer information

Organization name: Oystershell NV
SRN: BE-MF-000011797
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW999
For external use only. Diabetics with foot problems should consult their doctor when starting to use SOLVER. Stop using SOLVER and consult the GP if worsening of the symptoms is observed. Stop using SOLVER if not stored following recommended conditions for storage. Do not use if you are hypersensitive or allergic to any of the ingredients. This product is not suitable for children. Do not use in subjects with cutaneous pathologies other than onychomycosis on the skin surrounding the treated nail. Do not apply cosmetic, nor local medications on the nail treated. Do not use in subjects suffering from superficial toenail onychomycosis or light to moderate disto-lateral nail onychomycosis with matrix involvement and/or involvement > 2/3 of nail plate. In case > 50% nail plate involvement, more than three toenails involved, or presence of dermatophytoma, systemic therapy should be considered.
CW010
Consult instructions for use
CW011
Caution
CW135
Keep out of reach of children
CW032
Do not use past indicated date
CW084
Causes serious eye damage
CW416
IF IN EYES Rinse cautiously with water for several minutes.
CW275
Ask your pharmacist or doctor for advice before using or taking the product (e.g. if pregnant or breastfeeding)
CW148
Keep container tightly closed
CW082
Causes skin irritation

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement		Still on market
Slovakia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05410765006318
Basic UDI-DI: 5410765SolverRT
Reference / catalog number: 07011593
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M0410DRESSINGS FOR NAILS IN THE FORM OF LIQUIDS, GELS AND CREAMS

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

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Expiration date
Manufacturing date
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Software identification