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Silicone Self-adhering Male External Catheters
EUDAMEDClass I (EU MDR)
Ref MC35-30
Identity
- Trade Name
- Silicone Self-adhering Male External Catheters EUDAMED
- Device Name
- Silicone Self-adhering Male External Catheters EUDAMED
- Model / Reference
- MC35-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615370004724 EUDAMED
- Basic UDI-DI
- 697458912WB6U EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
Silicone Self-adhering Male External Catheters by Medalliance (Changzhou) Medical Instrument Co., Ltd. — Class I — CE/MDR — listed in EUDAMED
Similar devices
Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
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- 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 | 697458912WB6U | Class I | Active |
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Manufacturer
- Manufacturer
- Medalliance (Changzhou) Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000032943
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED c5b240d3-a814-41f5-ab96-f6b73cd4833e 61 fields · synced Oct 7, 2026