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Organization name
UDI-DI code
Reference / catalog number

Obesimed Forte 42 c — Class IIa MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on May 6, 2026

Obesimed Forte 42 c

B-165412P4

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-165412P4
Reference / catalog number: 165412

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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 use Obesimed® Forte in the following situations: - If you are allergic to one or more of the ingredients; - If you have suffered from gastrointestinal disorders; - If you have suffered from esophageal stenosis or pre-existing bowel abnormalities; - When pregnant or breastfeeding. • If you have any doubts about whether you can use Obesimed® Forte and/or can use it in combination with medication, consult your doctor or pharmacist first. • Do not open the capsule before using. • Keep out of reach of small children. Possible side effects: Obesimed® Forte is well tolerated but can lead to a few side effects although not everybody suffers from these side effects. Mild stomach and intestinal complaints may be experienced initially such as thin or loose stools, mild diarrhea, reflux and gas formation or constipation. Usually these side effects disappear after a few days. To avoid these side effects start with a low dosage (1 capsule per meal) and then gradually increase the intake as the body adjusts. If any of these side effects becomes serious, or if you notice any side effects not listed in this instructions for use, consult your doctor or pharmacist. Use during pregnancy and/or breastfeeding: Losing weight is not allowed when pregnant or breastfeeding

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 21, 2017	Still on market

Device identification

Trade name: Obesimed Forte 42 c
UDI-DI code: D-165412P4
Basic UDI-DI: B-165412P4
Reference / catalog number: 165412
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 obesity and overweight in adults
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-165412P4

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.

G0402ORALLY ADMINISTERED DEVICES FOR APPETITE CONTROL AND REDUCTION OF INTESTINAL ABSORPTION

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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