Identity
- Trade Name
- Hollister EUDAMEDVaPro Plus Pocket FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- No Touch Urethral Intermittent Catheter with intergrated collection bag, Nelaton EUDAMEDNo Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve FDA UDI
- Model / Reference
- 71142 EUDAMED71124 EUDAMEDFDA UDI
- Description
- No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve FDA UDI
Identifiers
- Catalog Number
- 71124 FDA UDI
- Primary DI / UDI-DI
- 00610075094424 EUDAMEDFDA UDI00610075053834 EUDAMED
- Basic UDI-DI
- 610075D03P093S0357DJ EUDAMED610075D03P079S0263EL EUDAMED
- Unit of Use DI
- 20610075094428 EUDAMED00610075065318 EUDAMED
- 510(k) Number
- K233524 FDA UDI
- FDA Product Code
- GBM 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
- Ireland 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
Yes
Dimensions & Sizes
- Size
- Catheter Gauge — 12 French FDA UDICatheter Length — 40 Centimeter FDA UDI
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
Hollister by Hollister Incorporated — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- 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
- HOMECATH — İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi · Class IIa
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 610075D03P093S0357DJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hollister Incorporated
- EUDAMED SRN
- US-MF-000027818
- Authorised Representative
- Hollister ULC IE-AR-000022119
Sources (4)
- EUDAMED 212e2666-71bb-4ed5-a0c1-70cae7896bee 61 fields · synced Oct 9, 2026
- EUDAMED 8280b687-74bc-4672-86e1-dd4c4349bd22 61 fields · synced May 17, 2026
- FDA UDI b1e4c341-348a-49cc-94e7-3493b50926b8 38 fields · synced May 27, 2026
- EUDAMED 7541d1eb-4a5f-47bc-818d-ddaf5d473dde 61 fields · synced Oct 7, 2026