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Organization name
UDI-DI code
Reference / catalog number

HEDRIN ONCE NATURAL LOTION — Class I MDR by Oystershell NV

MD Atlas
Oystershell NV

EUDAMED last updated this device on Nov 28, 2025

HEDRIN ONCE NATURAL LOTION

5410765ElimaGreen5T

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oystershell NV
UDI-DI code: 05410765005472
Reference / catalog number: 07011529

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Manufacturer information

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

Critical warnings

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

CW999
For external use only. Do not swallow. Avoid contact with eyes and mucus membranes (mouth and nose) Do not use a covering over treated hair like a shower cap or foil. Do not use if scalp is irritated or injured. Do not use if you have ever had an allergic reaction to any of this product’s ingredients. Stop use if signs of rash or irritation occur. Do not use longer than directed or overnight while sleeping. If the treatment is applied in the evening, make sure the hair is completely dry before going to bed. Do not use a hair dryer. This product is only suitable for head lice (not suitable for pubic or body lice). Not suitable for children under 6 months
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.
CW140
Do not spray on an open flame or other ignition source.
CW285
IF SWALLOWED Call a POISON CENTER or doctor/physician.
CW416
IF IN EYES Rinse cautiously with water for several minutes.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: HEDRIN ONCE NATURAL LOTION
UDI-DI code: 05410765005472
Basic UDI-DI: 5410765ElimaGreen5T
Reference / catalog number: 07011529
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: —
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

Related devices

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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.