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AMSure® Red Rubber Urethral Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AS44016Ref AS44014Ref AS44018Ref AS44028Ref AS44026Ref AS44008Ref AS44010Ref AS44022
Identity
- Trade Name
- AMSure® Red Rubber Urethral Catheter EUDAMEDFDA UDI
- Generic Name
- Ureteral catheter FDA UDI
- Device Name
- Urethral Catheter EUDAMEDAMSure® Red Rubber Urethral Catheter FDA UDI
- Model / Reference
- AS44016 EUDAMEDAS44014 EUDAMEDAS44018 EUDAMEDAS44028 EUDAMEDAS44026 EUDAMEDAS44008 EUDAMEDAS44010 EUDAMEDAS44022 EUDAMED1 FDA UDI
- Description
- AMSure® Red Rubber Urethral Catheter FDA UDI
Identifiers
- Catalog Number
- AS44016 FDA UDIAS44010 FDA UDIAS44028 FDA UDIAS44018 FDA UDIAS44008 FDA UDIAS44014 FDA UDIAS44022 FDA UDIAS44026 FDA UDI
- Primary DI / UDI-DI
- 10704411001829 EUDAMEDFDA UDI10704411001799 EUDAMEDFDA UDI10704411001881 EUDAMEDFDA UDI10704411001836 EUDAMEDFDA UDI10704411001782 EUDAMEDFDA UDI10704411001812 EUDAMEDFDA UDI10704411001850 EUDAMEDFDA UDI10704411001874 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411001829 EUDAMEDB-10704411001812 EUDAMEDB-10704411001836 EUDAMEDB-10704411001881 EUDAMEDB-10704411001874 EUDAMEDB-10704411001782 EUDAMEDB-10704411001799 EUDAMEDB-10704411001850 EUDAMED
- FDA Product Code
- EYB FDA UDI
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
- GMDN Term
- Ureteral catheter 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Category: Ureteral catheter
AMSure® Red Rubber Urethral Catheter by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral catheter.
- Bard® Polyurethane Ureteral Catheters, Open Tip — C. R. Bard, Inc. · Class II
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Bard® Woven Ureteral Catheter — C. R. Bard, Inc. · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Coloplast — Coloplast A/S · Class II
- UroForce® Balloon Dilation Catheter — C. R. Bard, Inc. · Class II
- Metal Catheter — RZ-Medizintechnik GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 (16)
- FDA UDI 16747484-2b16-4585-be5f-f7f776159a2a 34 fields · synced Aug 3, 2026
- FDA UDI e139b941-e3eb-426e-9634-c11104677994 34 fields · synced May 29, 2026
- FDA UDI 495c51c5-5440-4cfd-b7ce-08b607abc926 34 fields · synced May 29, 2026
- FDA UDI 49a592c3-cec7-43ab-927f-96891f086a78 34 fields · synced May 30, 2026
- FDA UDI c6d1060a-5a84-4736-af05-3cf7f0d7d4fa 34 fields · synced May 30, 2026
- FDA UDI e94f9d2e-1332-4fb6-a961-7cde6dc0598b 34 fields · synced May 30, 2026
- FDA UDI 1eeb9aeb-3ae3-499a-9eb5-f3390b0e04b2 34 fields · synced May 30, 2026
- FDA UDI 8582f695-2401-4e0d-892b-2a8348143762 34 fields · synced May 30, 2026
- EUDAMED a8714f6d-3435-4c85-ae09-f5006b5f373e 61 fields · synced Jul 15, 2026
- EUDAMED fdc3d0fc-66a3-403c-a512-9934bc557038 61 fields · synced Jul 16, 2026
- EUDAMED bfeaa379-bfa0-414d-9329-86f3eaaf0302 61 fields · synced Jul 19, 2026
- EUDAMED 5d551dc6-013c-4eb9-90b6-d32f74a4b248 61 fields · synced Jul 20, 2026
- EUDAMED 18b72f37-3389-4cc9-96a0-e33c173dcbd2 61 fields · synced Jul 21, 2026
- EUDAMED e344cd76-6b20-4a3f-b258-c5c50275327f 61 fields · synced Jul 31, 2026
- EUDAMED d5b45900-2233-4286-9ac7-4e03efcc1702 61 fields · synced Aug 2, 2026
- EUDAMED 4f06cc4c-ff33-422d-afba-bebdf774acb7 61 fields · synced Aug 3, 2026