AMSure®HG Hydrophilic Intermittent Urethral Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- AMSure® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve EUDAMEDAMSure®HG Hydrophilic Intermittent Urethral Catheter FDA UDI
- Generic Name
- Intermittent urethral drainage catheter, non-antimicrobial, single-use FDA UDI
- Device Name
- Hydrophilic Intermittent Catheter EUDAMEDAMSure ® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve 12Fr FDA UDI
- Model / Reference
- HG971612SS EUDAMED1 FDA UDI
- Description
- AMSure ® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve 12Fr FDA UDI
Identifiers
- Catalog Number
- HG971612SS FDA UDI
- Primary DI / UDI-DI
- 10704411008873 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411008873 EUDAMED
- FDA Product Code
- EZD FDA UDI
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
- GMDN Term
- Intermittent urethral drainage catheter, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
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
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
AMSure®HG Hydrophilic Intermittent Urethral Catheter by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
- CompactCath Nelaton, Female, 14 Fr/Ch, 19cm — Lentismed d.o.o. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (2)
- FDA UDI 79f63c6c-0899-4fad-9f76-0f22c170dcae 34 fields · synced Oct 6, 2026
- EUDAMED 6297cab1-802f-4bda-901b-cb06dcc94f98 61 fields · synced Jul 11, 2026