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Organization name
UDI-DI code
Reference / catalog number

CYS-CONTROL ULTRA — Class IIa MDD by Noventure S.L.U.

MD Atlas
Noventure S.L.U.

EUDAMED last updated this device on Mar 18, 2025

CYS-CONTROL ULTRA

B-1313022UN

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Noventure S.L.U.
UDI-DI code: D-1313022UN
Reference / catalog number: 1313022

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Manufacturer information

Organization name: Noventure S.L.U.
SRN: ES-MF-000000797
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Mar 24, 2025	Still on market

Device identification

Trade name: CYS-CONTROL ULTRA
UDI-DI code: D-1313022UN
Basic UDI-DI: B-1313022UN
Reference / catalog number: 1313022
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

G0499ORALLY ADMINISTERED GASTROINTESTINAL DEVICES - OTHER

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

Certificate health across this manufacturer's portfolio.

CVD0023230226Amended
Technical documentationNotified body: 0373Expiry: Dec 21, 2028
CSQ0016230226Amended
Quality management systemNotified body: 0373Expiry: Dec 21, 2028
MDR 00064-AIssued
Quality management systemNotified body: 0476Expiry: Nov 14, 2029
MDR00064-CIssued
Quality management systemNotified body: 0476Expiry: Nov 14, 2029