BD Intermittent Catheter
by Hangzhou Bever Medical Devices Co., Ltd. United States EUDAMEDGUDID
Ref BUC12C
Product code GBMEMDN U01010602
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69487962TC0001SJ | Date8 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06948796203868 | Date8 Dec 2020 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- BD Intermittent Catheter EUDAMEDBD Intermittent GUDID
- Generic Name
- Single-administration urethral drainage catheter
- Device Name
- Intermittent Catheter
- Model / Ref / Catalog
- BUC12C
- Primary DI / UDI-DI
- 06948796203868
- Basic UDI-DI
- 69487962TC0001SJ
- 510(k) Number
- FDA Product Code
- GBM
- EMDN Code
- U01010602 Tiemann catheters, non self-lubricating
- GMDN Term
- Single-administration urethral drainage catheter
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 876.5130
- Market of Registration
- Poland
- Commercial Distribution
- In Commercial Distribution
- Size
- Catheter Gauge — 12 FrenchCatheter Length — 16 Inch
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000018408
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Hangzhou Bever Medical Devices Co., Ltd.
See all devices from Hangzhou Bever Medical Devices Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED b1e30164-7292-4669-9778-98db852df0a3
- FDA UDI e8f5ed56-5c16-445d-bd4e-5ec30166211f