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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

GAMMA-AM — Class IIb MDD by CLErmont RAyonnement…

MD Atlas
CLErmont RAyonnement Détection

EUDAMED last updated this device on May 21, 2026

GAMMA-AM

B-03665632000421

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: CLErmont RAyonnement Détection
UDI-DI code: 03665632000421
Reference / catalog number: GS II 5000 RAD 5001 RAD 5002 RAD 5003 RAD 5004

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Manufacturer information

Organization name: CLErmont RAyonnement Détection
SRN: FR-MF-000033379
Manufacturer status: Active

Critical warnings

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

CW259
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jan 1, 2001	Still on market

Device identification

Trade name: GAMMA-AM
UDI-DI code: 03665632000421
Basic UDI-DI: B-03665632000421
Reference / catalog number: GS II 5000 RAD 5001 RAD 5002 RAD 5003 RAD 5004
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Sonde de détection GAMMA pour la surveillance isotopique des fuites médicamenteuses radiomarquées
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11029001BETA/GAMMA DETECTORS
Z11010301BRACHYTHERAPY RADIATION SYSTEMS

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

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.

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