← Back to catalogue
Hekura Urethral Catheter
EUDAMEDClass IIb (EU MDR)
Ref UZ6614Model Two-wayRef UZ6618Ref UZ6616Ref UZ6620Ref UZ6622
Identity
- Trade Name
- HEKURA URETHRAL CATHETER EUDAMED
- Device Name
- Urethral Catheter EUDAMED
- Model / Reference
- Two-way EUDAMEDUZ6614 EUDAMEDUZ6618 EUDAMEDUZ6616 EUDAMEDUZ6620 EUDAMEDUZ6622 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16955824086864 EUDAMED16955824088028 EUDAMED16955824087489 EUDAMED16955824088554 EUDAMED16955824089070 EUDAMED
- Basic UDI-DI
- 69558240CS0400100US00016R EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
Hekura Urethral Catheter by Conod Medical Co., Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
- Sunmed — SunMed · Class II
- Dover — Cardinalhealth · Class II
- Silicone Foley Catheters — Dynarex Corp. · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- Porges Coloplast — Coloplast A/S · Class II
- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69558240CS0400100US00016R | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conod Medical Co., Limited
- EUDAMED SRN
- CN-MF-000012600
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED d841af9d-d38b-4a52-86f0-968e54aae4b0 61 fields · synced Jul 28, 2026
- EUDAMED 4f84935a-ae0e-4ba7-b5a7-77e9725b7363 61 fields · synced May 17, 2026
- EUDAMED 1d671ef7-aa24-488b-b76f-84c898e59b23 61 fields · synced May 17, 2026
- EUDAMED 9b4e03d3-1098-4ea3-88f3-d4ca84a501b6 61 fields · synced May 18, 2026
- EUDAMED 432bee57-7e6a-4eaf-bca6-5fc83c1c867b 61 fields · synced May 19, 2026