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Organization name
UDI-DI code
Reference / catalog number

Sorisen — Class IIa MDR by DEVINTEC SAGL

MD Atlas
DEVINTEC SAGL

EUDAMED last updated this device on Oct 24, 2025

Sorisen

7649993626FT42305VL

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DEVINTEC SAGL
UDI-DI code: 07649993626199
Reference / catalog number: C43E07L100

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Manufacturer information

Organization name: DEVINTEC SAGL
SRN: CH-MF-000020271
Manufacturer status: Active

Critical warnings

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

CW135
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: Sorisen
UDI-DI code: 07649993626199
Basic UDI-DI: 7649993626FT42305VL
Reference / catalog number: C43E07L100
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 100
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 100 ml

EMDN nomenclature code(s)

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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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On the market

Certificates

Certificate health across this manufacturer's portfolio.

IT325651Supplemented
Quality management systemNotified body: 1370Expiry: Sep 7, 2028
IT326645Supplemented
Technical documentationNotified body: 1370Expiry: Sep 7, 2028
IT336677Issued
Quality management systemNotified body: 1370Expiry: Sep 7, 2028