Identity
- Trade Name
- Catheter-positioning guiding system EUDAMED
- Device Name
- Catheter-positioning guiding system EUDAMED
- Model / Reference
- U8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429021134 EUDAMED
- Basic UDI-DI
- 69454290CG001HH EUDAMEDB-06945429021134 EUDAMED
- Direct Marketing DI
- 06945429021134 EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Catheter-positioning guiding system by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69454290CG001HH | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69454290CG001HH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED ec3b3089-4f77-4061-8c80-de66c732fcec 61 fields · synced Oct 6, 2026
- EUDAMED 4dc3bce4-9ac9-4dca-832b-f40a38628cc6 61 fields · synced May 19, 2026