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BD Ready-to-Use Hydrophilic Catheter
EUDAMEDFDA UDIClass I (EU MDR)
Ref RTU12FRef RTU10PRef RTU12MRef RTU14M
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
- RTU12F EUDAMEDFDA UDIRTU10P EUDAMEDFDA UDIRTU14M EUDAMEDFDA UDIRTU12M EUDAMEDFDA UDI
- Description
- BD Ready-To-Use Hydrophilic Catheter FDA UDI
Identifiers
- Catalog Number
- RTU12F FDA UDIRTU10P FDA UDIRTU14M FDA UDIRTU12M FDA UDI
- Primary DI / UDI-DI
- 06948796204056 EUDAMEDFDA UDI06948796204032 EUDAMEDFDA UDI06948796203967 EUDAMEDFDA UDI06948796203950 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 12 French FDA UDICatheter Length — 7.5 Inch FDA UDICatheter Gauge — 10 French FDA UDICatheter Length — 10 Inch FDA UDICatheter Gauge — 14 French FDA UDICatheter Length — 16 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
European Union Active
CE/MDR
United States Pending data
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 (10)
- EUDAMED 74d5ce5e-f980-4d51-8cf4-5956d0b87cb2 61 fields · synced Jul 17, 2026
- EUDAMED d73d7c9e-5afc-4af4-8e02-48e366b889c2 61 fields · synced May 18, 2026
- FDA UDI 511ba4cc-2a6f-4055-af66-d968f12105ac 37 fields · synced May 30, 2026
- FDA UDI f3922306-07ac-4bfd-a963-0f2eb2735444 37 fields · synced May 30, 2026
- FDA UDI 42db3537-2bbd-4307-9fd9-20f02b329ca5 37 fields · synced May 30, 2026
- FDA UDI ef3b7164-8200-476e-bad6-c1bfaa524f55 37 fields · synced May 30, 2026
- EUDAMED eeb6bbca-9091-41d4-a6b1-aa0ff783e64e 61 fields · synced Jun 19, 2026
- EUDAMED cb5adb90-e2a2-43f9-96cb-715a830363e1 61 fields · synced Jul 14, 2026
- EUDAMED ebb5c0bd-7ecf-40f6-8c9e-27a9ccbba34b 61 fields · synced Jul 16, 2026
- EUDAMED c0f2d946-38ed-4dc6-b78b-28f57353d5e2 61 fields · synced Jul 17, 2026