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Organization name
UDI-DI code
Reference / catalog number

Sandoval Gas & Bloating — Class IIa MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on May 5, 2026

Sandoval Gas & Bloating

B-072135NA

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-072135NA
Reference / catalog number: 072135

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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
Warnings: • Do not take Gas & Bloating Relief capsules if you are hypersensitive or allergic to any of the ingredients; • Do not chew or bite the capsules. The capsules must not dissolve in the mouth; • Keep out of reach of children; • Not suitable for children under the age of 12. Do not take Gas &Bloating Relief capsules if you are hypersensitive or allergic to any of the ingredients Possible side effects: Gastrointestinal symptoms are the main side effects of taking natural mineral clay. These may include abdominal pain, bloating, constipation, diarrhoea and flatulence. Use during pregnancy and/or breastfeeding: As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional 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	Sep 14, 2018	Still on market

Device identification

Trade name: Sandoval Gas & Bloating
UDI-DI code: D-072135NA
Basic UDI-DI: B-072135NA
Reference / catalog number: 072135
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: To treat gastrointestinal disorders (gas abdominal pain, discomfort and flatulence) in adult and children 12 years and older
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-072135NA

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.

G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

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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