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Sterile Urinary Catheter for single use
EUDAMEDClass IIa (EU MDR)
Ref NAModel Silicone-2-way-2.0mm(6Fr/CH)-(Balloon capacity: 1.5cc/ml)、Silicone-2-way-2.7mm(8Fr/CH)-(Balloon capacity: 1-2cc/ml) 、Silicone-2-way-3.3mm(10Fr/CH)-(Balloon capacity: 3-5ml)、Silicone-2-way-4.0mm(12Fr/CH)-(Balloon capacity: 5-10ml)
Identity
- Device Name
- Sterile Urinary Catheter for single use EUDAMED
- Model / Reference
- Silicone-2-way-2.0mm(6Fr/CH)-(Balloon capacity: 1.5cc/ml)、Silicone-2-way-2.7mm(8Fr/CH)-(Balloon capacity: 1-2cc/ml) 、Silicone-2-way-3.3mm(10Fr/CH)-(Balloon capacity: 3-5ml)、Silicone-2-way-4.0mm(12Fr/CH)-(Balloon capacity: 5-10ml) EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26933298296917 EUDAMED
- Basic UDI-DI
- 69332982010V5 EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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: Intermittent urethral drainage catheter, non-antimicrobial, single-use
Sterile Urinary Catheter for single use by Jiangsu Suyun Medical Materials Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
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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 | 69332982010V5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Suyun Medical Materials Co., Ltd.
- EUDAMED SRN
- CN-MF-000021132
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED db2d98df-4135-43c3-9e12-6bd07ef2bef3 61 fields · synced Jun 19, 2026