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Intermittent Catheter
EUDAMEDFDA UDIClass I (EU MDR)
Ref 850162-000160Ref BUC10PRef BUC14MRef BUC08PRef BUC12MRef BUC12CRef BUC14FRef BUC06PRef BUC16CRef BUC16M
Identity
- Trade Name
- Intermittent Catheter EUDAMEDBD Intermittent Catheter EUDAMEDBD Intermittent FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- Intermittent Catheter EUDAMEDBD Intermittent Catheter FDA UDI
- Model / Reference
- 850162-000160 EUDAMEDBUC10P EUDAMEDFDA UDIBUC14M EUDAMEDFDA UDIBUC08P EUDAMEDFDA UDIBUC12M EUDAMEDFDA UDIBUC12C EUDAMEDFDA UDIBUC14F EUDAMEDFDA UDIBUC06P EUDAMEDFDA UDIBUC16C EUDAMEDFDA UDIBUC16M EUDAMEDFDA UDI
- Description
- BD Intermittent Catheter FDA UDI
Identifiers
- Catalog Number
- BUC08P FDA UDIBUC12C FDA UDIBUC16C FDA UDIBUC12M FDA UDIBUC14F FDA UDIBUC16M FDA UDIBUC06P FDA UDIBUC14M FDA UDIBUC10P FDA UDI
- Primary DI / UDI-DI
- 16948796205500 EUDAMED06948796203912 EUDAMEDFDA UDI06948796203844 EUDAMEDFDA UDI06948796203905 EUDAMEDFDA UDI06948796203837 EUDAMEDFDA UDI06948796203868 EUDAMEDFDA UDI06948796203943 EUDAMEDFDA UDI06948796203899 EUDAMEDFDA UDI06948796203882 EUDAMEDFDA UDI06948796203851 EUDAMEDFDA UDI
- Basic UDI-DI
- 69487962NC0001Q4 EUDAMED69487962TC0001SJ EUDAMED
- 510(k) Number
- K111405 FDA UDI
- FDA Product Code
- GBM FDA UDI
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMEDU01010602 TIEMANN CATHETERS, NON 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
- Italy EUDAMEDPoland 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 — 8 French FDA UDICatheter Length — 10 Inch FDA UDICatheter Gauge — 12 French FDA UDICatheter Length — 16 Inch FDA UDICatheter Gauge — 16 French FDA UDICatheter Gauge — 14 French FDA UDICatheter Length — 6.3 Inch FDA UDICatheter Gauge — 6 French FDA UDICatheter Gauge — 10 French FDA UDI
Intermittent Catheter by Hangzhou Bever Medical Devices Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 69487962NC0001Q4 | 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 (29)
- EUDAMED 2971fced-1433-498d-8c50-619be51007e0 61 fields · synced Jul 31, 2026
- EUDAMED 092e8fe9-4a09-4413-80ed-498f24ae7948 61 fields · synced May 16, 2026
- EUDAMED 80a8f2a0-f56d-4530-9f81-d5e5abc728be 61 fields · synced May 17, 2026
- EUDAMED 199ba99d-227c-4503-aa64-565f55193bde 61 fields · synced May 17, 2026
- EUDAMED c8095f74-e426-4158-90c0-58ad3e9df9ef 61 fields · synced May 18, 2026
- EUDAMED b1e30164-7292-4669-9778-98db852df0a3 61 fields · synced May 18, 2026
- EUDAMED 5c19facf-7467-468c-b79e-880111d5347a 61 fields · synced May 18, 2026
- EUDAMED 6ac22dab-de53-4054-a6bd-28c2c0ca56c8 61 fields · synced May 18, 2026
- EUDAMED 70b24b75-972e-47da-a4fa-5d7c1ed8929b 61 fields · synced May 18, 2026
- EUDAMED d3c3f6e8-c077-4331-aa15-bc85632f2625 61 fields · synced May 19, 2026
- FDA UDI 3fcf2c7a-36fb-4efa-9ea7-560a0cb2f26e 37 fields · synced May 29, 2026
- FDA UDI e8f5ed56-5c16-445d-bd4e-5ec30166211f 37 fields · synced May 29, 2026
- FDA UDI 1fd7cfe4-32c9-4429-a5c4-93fe2f42f0d6 37 fields · synced May 30, 2026
- FDA UDI a509549d-76f4-4352-b198-a2d551019eb5 37 fields · synced May 30, 2026
- FDA UDI 101d757e-88d2-48af-8e7d-341d1a754242 37 fields · synced May 30, 2026
- FDA UDI 8a4abdf6-ffa5-4fa2-aab5-08810cb9be2c 37 fields · synced May 30, 2026
- FDA UDI c2828745-cb66-4601-af9e-9970b6d35bbc 37 fields · synced May 30, 2026
- FDA UDI a001b85f-d5d4-4870-8f23-904df891a7c5 37 fields · synced May 30, 2026
- FDA UDI a0962560-5e89-4b1d-8297-a12c75bec5f0 37 fields · synced May 30, 2026
- EUDAMED d4ce47cd-fefc-4349-ba13-56934053b8b6 61 fields · synced Jul 9, 2026
- EUDAMED deb4578d-bcfc-4f1b-964d-2598d287cef1 61 fields · synced Jul 9, 2026
- EUDAMED 2587255e-eb8b-4213-99e1-d39d99846d80 61 fields · synced Jul 11, 2026
- EUDAMED 5291b9d2-9115-4e6f-bc36-78be9d15f294 61 fields · synced Jul 12, 2026
- EUDAMED 0b8d7129-e53a-458c-b941-ffbc54f7ef73 61 fields · synced Jul 16, 2026
- EUDAMED a6f3a43d-f358-4267-8400-4265bf9dd500 61 fields · synced Jul 17, 2026
- EUDAMED 420e8a8d-5a38-4262-b171-2f7eceede463 61 fields · synced Jul 18, 2026
- EUDAMED 946b6134-65d5-450a-8c44-ca53cc7214af 61 fields · synced Jul 24, 2026
- EUDAMED 6697905b-1700-494e-ab4e-c6c7837c3ce1 61 fields · synced Jul 29, 2026
- EUDAMED 0d912183-941d-4580-bc95-2db757dc1ad7 61 fields · synced Jul 31, 2026