Identity
- Trade Name
- AMSure® Urinary Leg Bag EUDAMEDFDA UDI
- Generic Name
- Wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Urine Bag EUDAMEDAMSure® Urinary Leg Bag Large - 900 ml, T-tap Valve CONTENTS: One each 900 mL leg bag equipped with: T-valve drainage outlet Anti-reflux valve Two latex-free straps FDA UDI
- Model / Reference
- AS309T EUDAMED1 FDA UDI
- Description
- AMSure® Urinary Leg Bag Large - 900 ml, T-tap Valve CONTENTS: One each 900 mL leg bag equipped with: T-valve drainage outlet Anti-reflux valve Two latex-free straps FDA UDI
Identifiers
- Catalog Number
- AS309T FDA UDI
- Primary DI / UDI-DI
- 10704411008309 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411008309 EUDAMED
- FDA Product Code
- FAQ FDA UDI
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
- GMDN Term
- Wearable adult urine collection bag, open-ended FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5250 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wearable adult urine collection bag, open-ended
AMSure® Urinary Leg Bag by Amsino International, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wearable adult urine collection bag, open-ended.
- SteriGear — Sterigear, LLC · Class II
- Urine Bag — Well Lead Medical Co., Ltd · Class II
- Urine Bag — Well Lead Medical Co., Ltd · Class II
- Flexicare — FLEXICARE MEDICAL LIMITED · Class I
- Urine Bag — Well Lead Medical Co., Ltd · Class II
- Flexicare — FLEXICARE MEDICAL LIMITED · Class I
- Leg Bag — C. R. Bard, Inc. · Class I
- Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) — UROCARE PRODUCTS, INC. · Class II
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 I | Unknown |
| 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
- Amsino International, Inc.
Sources (2)
- FDA UDI 7baa5e4e-f8db-493f-b75c-88be8c51937d 34 fields · synced Oct 6, 2026
- EUDAMED c2f4e584-5bab-4f06-a449-74d8c2319fb8 61 fields · synced Oct 6, 2026