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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

PC-v01 — Class I MDD by SOFTWAY MEDICAL

MD Atlas
SOFTWAY MEDICAL

EUDAMED last updated this device on Oct 10, 2024

PC-v01

B-PC-v01EY

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SOFTWAY MEDICAL
UDI-DI code: D-PC-v01EY
Reference / catalog number: PC-v01

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Manufacturer information

Organization name: SOFTWAY MEDICAL
SRN: FR-MF-000009085
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	May 3, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-PC-v01EY
Basic UDI-DI: B-PC-v01EY
Reference / catalog number: PC-v01
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: PHMCalc est destiné à calculer l’activité radioactive optimale à dispenser et à administrer en médecine nucléaire. Principe de fonctionnement : Le dispositif calcule l’activité radioactive optimale à dispenser en fonction des données patient (poids, taille, âge, sexe, etc.), en se basant sur les abaques spécifiques à chaque examen et de l’heure d’administration prévue. Le dispositif génère des alertes lors de la traçabilité des processus de dispensation et d’administration des activités radioactives destinées aux patients si un extremum défini pour l'examen ou un écart non tolérable par rapport aux activités radioactives optimales calculées ou prescrites, est détecté.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11029092VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE

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

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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.