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Intermittent Catheter
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 850164-000140Ref 850160-000080Ref 850164-000100Ref 850164-000120Ref 850160-000060Ref 850164-000080Ref 850160-000120Ref 850164-000180Ref 850162-000140Ref 850160-000140510(k) K111405
Identity
- Trade Name
- Intermittent Catheter EUDAMED
- Device Name
- Intermittent Catheter EUDAMED
- Model / Reference
- 850164-000140 EUDAMED850160-000080 EUDAMED850164-000100 EUDAMED850164-000120 EUDAMED850160-000060 EUDAMED850164-000080 EUDAMED850160-000120 EUDAMED850164-000180 EUDAMED850162-000140 EUDAMED850160-000140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16948796205555 EUDAMED16948796205418 EUDAMED16948796205531 EUDAMED16948796205548 EUDAMED16948796205401 EUDAMED16948796205524 EUDAMED16948796205432 EUDAMED16948796205579 EUDAMED16948796205494 EUDAMED16948796205449 EUDAMED
- Basic UDI-DI
- 69487962TC0001SJ EUDAMED69487962NC0001Q4 EUDAMED
- 510(k) Number
- K111405 FDA 510(k)
- FDA Product Code
- GBM FDA 510(k)
- EMDN Code
- U01010602 TIEMANN CATHETERS, NON SELF-LUBRICATING EUDAMEDU01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5130 FDA 510(k)
- Regulation Number
- 876.5130 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Intermittent Catheter by Hangzhou Bever Medical Devices Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111405 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69487962TC0001SJ | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bever Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000018408
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (21)
- EUDAMED d539e5de-fa1f-4f31-9b8d-93aad6c17c0c 61 fields · synced Oct 1, 2026
- EUDAMED d02c9794-46ca-4384-9fa5-b54f243f99bc 61 fields · synced May 17, 2026
- EUDAMED 9106039b-e51d-4d8e-bd26-d7474ad3b466 61 fields · synced May 17, 2026
- EUDAMED 82b46010-4040-4e47-86e8-c2a1206500ce 61 fields · synced May 17, 2026
- EUDAMED cf3b26a5-3e92-4091-add9-a9d47eb07cbc 61 fields · synced May 17, 2026
- EUDAMED de02f7dd-82f3-4b76-a07d-5ddadcb6c41a 61 fields · synced May 17, 2026
- EUDAMED 627226d4-9f8a-4590-b956-99b35389164e 61 fields · synced May 17, 2026
- EUDAMED 54bab768-5255-42df-ad8d-5aa6ff26cdbc 61 fields · synced May 18, 2026
- EUDAMED 2f3be477-3b7b-4fe8-a5a5-b12499a5901a 61 fields · synced May 18, 2026
- EUDAMED 79520993-c3c2-4848-8932-4e238071f959 61 fields · synced May 18, 2026
- FDA 510(k) K111405 24 fields · synced May 18, 2026
- EUDAMED bc0514b9-aa93-44a4-8333-3e16f21fc9fa 61 fields · synced Jul 9, 2026
- EUDAMED 5042dc11-01a8-4706-acdd-30427fb544c5 61 fields · synced Jul 10, 2026
- EUDAMED 073eb0e7-f2e1-4ce3-af5b-9b096f352a4e 61 fields · synced Jul 11, 2026
- EUDAMED 6c4ad723-4134-455b-8361-755747c9c020 61 fields · synced Jul 14, 2026
- EUDAMED f9029a8e-ccbd-4ba5-a9ce-3a7b4bd023cd 61 fields · synced Jul 16, 2026
- EUDAMED 465c6d96-1384-4111-b801-b217400ce988 61 fields · synced Jul 16, 2026
- EUDAMED 0195e9dc-82ed-42f3-a5b0-152a7c037254 61 fields · synced Jul 28, 2026
- EUDAMED 0197d261-b159-40a4-91af-14206629ca65 61 fields · synced Jul 30, 2026
- EUDAMED e1602a30-4c59-4b8f-a595-896e30d8d0f0 61 fields · synced Aug 3, 2026
- EUDAMED bc753bfe-dcb9-4d6f-af88-564207e02f7d 61 fields · synced Oct 1, 2026