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Organization name
UDI-DI code
Reference / catalog number

ESPR-L04C — Class III MDD by SOFAR SWISS SA

MD Atlas
SOFAR SWISS SA

EUDAMED last updated this device on Feb 11, 2026

ESPR-L04C

B-07640158970614

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SOFAR SWISS SA
UDI-DI code: 07640158970614
Reference / catalog number: ESPR-L04C

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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 EXPR-L20CB-07640158970645On the market EXX-C04LB-07640158970638On the market EXX-C20LB-07640158970621On the market EXX-C04L764015897GERDOFFSEOn the market

Critical warnings

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

CW999
Contraindications: Known hypersensitivity to one of the components

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07640158970614
Basic UDI-DI: B-07640158970614
Reference / catalog number: ESPR-L04C
Issuing entity: GS1

Classification

Risk category: Class III
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)

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