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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

07030897 — Class I MDR by Oystershell NV

MD Atlas
Oystershell NV

EUDAMED last updated this device on May 21, 2025

07030897

5410765SilcapShampooG5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oystershell NV
UDI-DI code: 05410765007285
Reference / catalog number: 07030897

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Manufacturer information

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

Critical warnings

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

CW999
For external use only. Do not swallow Avoid contact with mucous membranes (mouth and nose). Avoid using a hair dryer. This product is only suitable for head lice (not suitable for pubic or body lice). Not suitable for children under 12 months. Do not use in case of hypersensitivity to any of the ingredients. In the case of a rash or signs of irritation/allergy, stop the treatment immediately. Do not use if you have known skin allergies, multiple drug allergies or multiple allergies to cosmetic products. Do not use on the scalp if you have a chronic disorder or open wound. Do not use for longer than 10 minutes or overnight while sleeping. Do not use the product under occlusion, e.g. by covering up the hair with a cap or wrapped foil.
CW010
Consult instructions for use
CW011
Caution
CW032
Do not use past indicated date
CW075
Toxic if swallowed.
CW135
Keep out of reach of children
CW139
Keep away from heat/sparks/open flames/hot surfaces. No smoking.
CW085
Causes serious eye irritation
CW285
IF SWALLOWED Call a POISON CENTER or doctor/physician.
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)

Market distribution

Primary placement in Portugal; available across 1 country total.

Country	On market since	Until
PortugalPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05410765007285
Basic UDI-DI: 5410765SilcapShampooG5
Reference / catalog number: 07030897
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: STOP PIOLHOS CHAMPÔ TRATAMENTO
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V901001LICE ELIMINATION MECHANICAL DEVICES

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

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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.