Identity
- Trade Name
- BD Ready-to-Use Hydrophilic Catheter EUDAMEDBD Intermittent FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- Ready-to-Use Hydrophilic Catheter EUDAMEDBD Ready-To-Use Hydrophilic Catheter FDA UDI
- Model / Reference
- RTU08P EUDAMEDFDA UDI
- Description
- BD Ready-To-Use Hydrophilic Catheter FDA UDI
Identifiers
- Catalog Number
- RTU08P FDA UDI
- Primary DI / UDI-DI
- 06948796204025 EUDAMEDFDA UDI
- Basic UDI-DI
- 69487962NC0003Q8 EUDAMED
- 510(k) Number
- K192468 FDA UDI
- FDA Product Code
- GBM FDA UDIEZD FDA UDI
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
- GMDN Term
- Single-administration urethral drainage catheter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Catheter Gauge — 8 French FDA UDICatheter Length — 10 Inch FDA UDI
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
BD Ready-to-Use Hydrophilic Catheter by Hangzhou Bever Medical Devices Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
- hi-slip plus — Wellspect HealthCare · Class I
- TruCath Oasis — H R Pharmaceuticals, Inc. · Class II
- SmoothCath™ — GELİŞİM MEDİKAL TIBBİ MALZ. PAZ. SAN. VE TİC. LTD. ŞTİ. · Class I
- PVC Hydrophilic Urethral Catheter — Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Class II
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
- CompactCath Nelaton, Female, 14 Fr/Ch, 19cm — Lentismed d.o.o. · Class I
- GoldCath — DEMERSAN BIYOTEKNOLOJI İMALAT SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69487962NC0003Q8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (3)
- EUDAMED a90dcc7a-e4d3-4937-a03c-1dad9a4f7a32 61 fields · synced Jun 19, 2026
- FDA UDI ebaedb8f-e557-41c8-b351-0fd6fbabeda7 37 fields · synced May 30, 2026
- EUDAMED 8ba41080-30fa-420e-ac4e-2a5b04ef1fce 61 fields · synced Jun 19, 2026