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

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  • MD Atlas
  • Rontis Corporation SA

Data from EUDAMED, last updated May 23, 2026

Europa Ultra Coronary Balloon Catheter

076300333EF_CBLCATHGG

110 references

Class III
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class III
Manufacturer
Rontis Corporation SA

Device family identification

Device name
Europa Ultra Coronary Balloon Catheter
Basic UDI-DI
076300333EF_CBLCATHGG
Device model
Europa Ultra™ Family
Issuing agency
GS1
Version date
Apr 4, 2024

Classification

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

Manufacturer & authorised representative

Manufacturer

Name
Rontis Corporation SA
SRN
CH-MF-000031411
Country
Switzerland
Email
info@rontis.com

Authorised representative

Name
RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.
SRN
GR-AR-000023077
Country
Greece
Phone
+302106109090

Device characteristics

No device characteristics flagged

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

  • C010401020101Ptca balloon dilation catheters

References by status

Legacy certificates

Certificate number
44912221174
Type
refdata.certificate-mdr-type.technical-documentation
Notified body
TÜV NORD CERT GmbH (0044)
Validity
Mar 15, 2024 → Mar 14, 2029

References

110 references

Export results

Applied filters

  • basicUdiUlid·01HTCZ53NH7EFBEV8SEDVHAY0B

Format

Summary

31 columns included
  • Trade name
  • Basic UDI-DI
  • UDI-DI code
  • Risk category
  • Applicable legislation
  • Status
  • Organization name
  • SRN
  • Reference / catalog number
  • Additional product description
  • Intended medical purpose
  • Market country
  • Issuing entity
  • Market info update date
  • Sterile
  • Single use
  • Contains latex
  • Reprocessed single-use
  • Direct marking
  • CMR substance
  • Endocrine disruptor
  • Annex XVI applicable
  • Sterilization
  • OEM applicable
  • EMDN codes
  • Last updated
  • Basic UDI-DI device name
  • Basic UDI-DI device model
  • Basic UDI-DI implantable
  • Basic UDI-DI reagent
  • DM Atlas link
Trade nameReference / catalog numberUDI-DI codeQuantityStatus
Europa Ultra™EL20/15076300333000251On the market
Europa Ultra™EL45/30076300333004071On the market
Europa Ultra™EN40/15076300333009711On the market
Europa Ultra™EN25/15076300333007731On the market
Europa Ultra™EC15/10076300333005371On the market
Europa Ultra™EN20/25076300333006981On the market
Europa Ultra™EN50/15076300333010771On the market
Europa Ultra™EL40/30076300333003531On the market
Europa Ultra™EO15/15076300333006431On the market
Europa Ultra™EN22/10076300333007111On the market
Europa Ultra™EL20/25076300333000491On the market
Europa Ultra™EO10/12076300333005751On the market
Europa Ultra™EL22/15076300333000701On the market
Europa Ultra™EL35/15076300333002781On the market
Europa Ultra™EL40/25076300333003461On the market
Europa Ultra™EL25/25076300333001481On the market
Europa Ultra™EO12/15076300333006121On the market
Europa Ultra™EN20/20076300333006811On the market
Europa Ultra™EL45/15076300333003771On the market
Europa Ultra™EN45/15076300333010221On the market
Europa Ultra™EC10/12076300333004761On the market
Europa Ultra™EL27/10076300333001621On the market
Europa Ultra™EN50/10076300333010601On the market
Europa Ultra™EO10/16076300333005821On the market
Europa Ultra™EN22/30076300333007591On the market