Identity
- Trade Name
- Sterile Urethral Catheter EUDAMED
- Device Name
- Sterile Urethral Catheter EUDAMED
- Model / Reference
- JF14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977434314802 EUDAMED
- Basic UDI-DI
- 6977434310501BH EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I 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
Sterile Urethral Catheter by Shaoxing Jiancheng Medical Products Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6977434310501BH | Class I | Active |
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Manufacturer
- Manufacturer
- Shaoxing Jiancheng Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000038893
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 57155ec9-fe93-43fe-aeae-8400c3679037 61 fields · synced Oct 6, 2026