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Webster Electrophysiology Catheter (37g58r / 37g58r)
EUDAMEDClass III (EU MDD (legacy))
Ref 37G58RRef 36C33RRef 36S30QRef 35Y13QRef 37U00R
Identity
- Trade Name
- WEBSTER ELECTROPHYSIOLOGY CATHETER EUDAMED
- Model / Reference
- 37G58R EUDAMED36C33R EUDAMED36S30Q EUDAMED35Y13Q EUDAMED37U00R EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF000014219000011Q9 EUDAMEDD-USMF000014219000017QM EUDAMEDD-USMF000014219000004QC EUDAMEDD-USMF000014219000002Q8 EUDAMEDD-USMF000014219000010Q7 EUDAMED
- Basic UDI-DI
- B-USMF000014219000011Q9 EUDAMEDB-USMF000014219000017QM EUDAMEDB-USMF000014219000004QC EUDAMEDB-USMF000014219000002Q8 EUDAMEDB-USMF000014219000010Q7 EUDAMED
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Legislation / Framework
- MDD (Directive 93/42/EEC on Medical Devices) EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Webster Electrophysiology Catheter (37g58r / 37g58r) by Biosense Webster Inc — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000014219000011Q9 | Class III | Active |
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Manufacturer
- Manufacturer
- Biosense Webster, Inc
- EUDAMED SRN
- US-MF-000014219
- Authorised Representative
- Biosense Webster A Division of Johnson & Johnson Medical NV/SA BE-AR-000012231
Sources (5)
- EUDAMED 66 fields · synced Jul 29, 2026
- EUDAMED a28710ba-1369-4084-91fb-c8255e7f387a 61 fields · synced Jul 8, 2026
- EUDAMED 70b6d205-ecc7-4953-9b33-b3179bee9ff7 61 fields · synced Jul 9, 2026
- EUDAMED daa783c0-676a-4952-8af6-81039909b29b 61 fields · synced Jul 9, 2026
- EUDAMED b28853fa-7a2a-448e-ab13-130f5e219d19 61 fields · synced Jul 29, 2026