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Organization name
UDI-DI code
Reference / catalog number

EXX-C04L — Class III MDR by SOFAR SWISS SA

MD Atlas
SOFAR SWISS SA

EUDAMED last updated this device on Nov 27, 2025

EXX-C04L

764015897GERDOFFSE

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SOFAR SWISS SA
UDI-DI code: 07640158970638
Reference / catalog number: EXX-C04L

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Manufacturer information

Organization name: SOFAR SWISS SA
SRN: CH-MF-000047475
Manufacturer status: Active

Related devices

ESPR-L20CB-07640158970607On the market ESPR-L04CB-07640158970614On the market EXPR-L20CB-07640158970645On the market EXX-C04LB-07640158970638On the market EXX-C20LB-07640158970621On the market

Critical warnings

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

CW999
Contraindications: Kidney failure. Hypophosphatemia. Known hypersensitivity to one of the ingredients

Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07640158970638
Basic UDI-DI: 764015897GERDOFFSE
Reference / catalog number: EXX-C04L
Issuing entity: GS1

Classification

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

Device details

Quantity: 4
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)

G99GASTROINTESTINAL 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

Certificates

Certificate health across this manufacturer's portfolio.

CSQ0028250625Supplemented
Quality management systemNotified body: 0373Expiry: Apr 23, 2030
CVD0043250625Supplemented
Technical documentationNotified body: 0373Expiry: Apr 23, 2030