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Organization name
UDI-DI code
Reference / catalog number

IN35/10 — Class III MDD by Rontis Corporation SA

MD Atlas
Rontis Corporation SA

EUDAMED last updated this device on Jun 28, 2023

IN35/10

B-07630033313148

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Rontis Corporation SA
UDI-DI code: 07630033313148
Reference / catalog number: IN35/10

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Manufacturer information

Organization name: Rontis Corporation SA
SRN: CH-MF-000031411
Manufacturer status: Active

Critical warnings

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

CW001
Referenced ISO15223-1:2021 symbol
CW007
Referenced ISO15223-1:2021 symbol
CW010
Referenced ISO15223-1:2021 symbol
CW009
Referenced ISO15223-1:2021 symbol

Market distribution

Primary placement in EL; available across 1 country total.

Country	On market since	Until
ELPrimary placement	Jan 1, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07630033313148
Basic UDI-DI: B-07630033313148
Reference / catalog number: IN35/10
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: 3.5 MU50
10 MU50

EMDN nomenclature code(s)

C010401020101PTCA BALLOON DILATION CATHETERS

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.

44912221174Issued
Technical documentationNotified body: 0044Expiry: Mar 14, 2029

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