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Organization name
UDI-DI code
Reference / catalog number

Obesimed Fit — Class IIa MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on May 6, 2026

Obesimed Fit

B-074368PH

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-074368PH
Reference / catalog number: 074368

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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 chew or bite on the capsules. De capsules must not be allowed to dissolve in the mouth; • Keep out of reach of young children; • If you experience allergic reactions, stop using this product; • Not suitable for children under the age of 12; • Do not take Flat belly if you are hypersensitive or allergic to any of the ingredients; • Flat belly should not be taken at the same time with another drug. Side effects: Digestive symptoms such as abdominal pain, diarrhoea, constipation, nausea and dyspepsia may occur in overdose. Use during pregnancy and/or breastfeeding: Please consult your doctor or pharmacist before using this product if you are pregnant or breastfeeding.

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Market distribution

Primary placement in Portugal; available across 1 country total.

Country	On market since	Until
PortugalPrimary placement	Feb 28, 2021	Still on market

Device identification

Trade name: Obesimed Fit
UDI-DI code: D-074368PH
Basic UDI-DI: B-074368PH
Reference / catalog number: 074368
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 gas-related visible abdominal distension 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-074368PH

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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