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Organization name
UDI-DI code
Reference / catalog number

Oral Medic Kids Mouth Ulcer — Class IIa MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on May 5, 2026

Oral Medic Kids Mouth Ulcer

B-072012MR

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-072012MR
Reference / catalog number: 072012

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View device family (Basic UDI)

Manufacturer information

Organization name: PK Benelux BV
SRN: NL-MF-000006672
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

1 warning recorded — scroll inside the panel to see all entries.

CW999
Warning: • Keep out of reach of small children; • Do not use Mouth Ulcer gel if you are oversensitive to one or more of the ingredients; • Do not use after the expiry date stated on the packaging. Possible side effects: To date, no side effects have been noted when using Mouth Ulcer gel. Use during pregnancy and/or breastfeeding: No data is available about using Mouth Ulcer gel during the pregnancy or breastfeeding period. If you are pregnant or breastfeeding, please consult your doctor or pharmacist before using this product.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	May 31, 2018	Still on market

Device identification

Trade name: Oral Medic Kids Mouth Ulcer
UDI-DI code: D-072012MR
Basic UDI-DI: B-072012MR
Reference / catalog number: 072012
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Symptomatic treatment of mouth ulcers and ulcers from braces and eliminate ulcer development in adults and children over 12 years of age with normal immune systems.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-072012MR

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M04041503DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS

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

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