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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Transi-Mark — Class IIa MDD by MARQUAT GENIE BIOMEDICAL

MD Atlas
MARQUAT GENIE BIOMEDICAL

EUDAMED last updated this device on Sep 13, 2022

Transi-Mark

B-03760372870102

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: MARQUAT GENIE BIOMEDICAL
UDI-DI code: 03760372870102
Reference / catalog number: C624

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Manufacturer information

Organization name: MARQUAT GENIE BIOMEDICAL
SRN: FR-MF-000014282
Manufacturer status: Active

Critical warnings

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

CW030
It is a prescription-only test
CW010
Do not chew or bite. Do not take laxatives or other medications that affect colonic transit during the test. If you forget to take a capsule, contact your doctor.
CW275
This test is not recommended for use during pregnancy or lactation

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jan 1, 1972	Still on market

Device identification

Trade name: Transi-Mark
UDI-DI code: 03760372870102
Basic UDI-DI: B-03760372870102
Reference / catalog number: C624
Issuing entity: GS1

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: Safe and reliable medical device for measuring Colonic Transit Time for patients with chronic constipation or other digestive disorders. Each capsule contains 10 radiopaque markers. Easily identifiable and quantifiable on the X-ray due to their shape, the markers are made of medical grade silicone impregnated with barium sulphate with recognized opacifying properties. These markers are contained in vegetable capsules made of hypromellose which disintegrate in the stomach. They are to be taken orally and will not be digested or metabolized and will pass naturally in the stool.
Additional information URL: https://www.transimark.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

G030703MARKERS FOR EVALUATION OF GASTROINTESTINAL PASSAGE

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

MARQUATB-03760372870003On the market

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.