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Organization name
UDI-DI code
Reference / catalog number

TRA01EP01V10 — Class IIb MDR by SILDEHA Swiss SA

MD Atlas
SILDEHA Swiss SA

Manufacturer information

Organization name: SILDEHA Swiss SA
SRN: CH-MF-000034348
Manufacturer status: Active

Certificates

Certificate health across this manufacturer's portfolio.

CSQ0025240124Supplemented
Quality management systemNotified body: 0373Expiry: Jul 14, 2029

EUDAMED last updated this device on Sep 25, 2025

TRA01EP01V10

764044938STLYSOLOFTHL

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SILDEHA Swiss SA
UDI-DI code: 07640449380054
Reference / catalog number: TRA01EP01V10

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Manufacturer information

Organization name: SILDEHA Swiss SA
SRN: CH-MF-000034348
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW999
- Do not use beyond the expiry date. The expiry date on the label refers to the product closed and correctly stored.
CW999
- Consult instructions for use
CW999
- Do not use if the package is open or damaged

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: 07640449380054
Basic UDI-DI: 764044938STLYSOLOFTHL
Reference / catalog number: TRA01EP01V10
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 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)

Q0299OPHTHALMIC 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.

CSQ0025240124Supplemented
Quality management systemNotified body: 0373Expiry: Jul 14, 2029

Manufacturer information

Certificates

Related devices

TRA01EP01V10

Manufacturer information

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Critical warnings

Market distribution

Device identification

Classification

Device details

EMDN nomenclature code(s)

Compliance flags

Safety

Substances

Regulatory

Lifecycle

UDI-PI traceability

Certificates