Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

IO10/16 — Class III MDD by Rontis Corporation SA

MD Atlas
Rontis Corporation SA

EUDAMED last updated this device on Jul 2, 2023

IO10/16

B-07630033313469

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Rontis Corporation SA
UDI-DI code: 07630033313469
Reference / catalog number: IO10/16

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

Europa Ultra™076300333EF_CBLCATHGGOn the market Europa Ultra™076300333EF_CBLCATHGGOn the market Europa Ultra™076300333EF_CBLCATHGGOn the market Europa Ultra™076300333EF_CBLCATHGGOn the market Europa Ultra™076300333EF_CBLCATHGGOn the market

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: 07630033313469
Basic UDI-DI: B-07630033313469
Reference / catalog number: IO10/16
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: 1 MU50
16 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