Identity
- Trade Name
- AMSure® Urinary Drainage Bag EUDAMEDFDA UDI
- Generic Name
- Non-wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Urine Bag EUDAMEDAMSure® Urinary Drainage Bag CONTENTS: One 2000mL drainage bag equipped with: T-valve drainage outlet, Air vent, Double hanger, Sampling adapter, Anti-reflux valve, Protective cap FDA UDI
- Model / Reference
- AS302 EUDAMED1 FDA UDI
- Description
- AMSure® Urinary Drainage Bag CONTENTS: One 2000mL drainage bag equipped with: T-valve drainage outlet, Air vent, Double hanger, Sampling adapter, Anti-reflux valve, Protective cap FDA UDI
Identifiers
- Catalog Number
- AS302 FDA UDI
- Primary DI / UDI-DI
- 10704411004097 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411004097 EUDAMED
- FDA Product Code
- KNX FDA UDI
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
- GMDN Term
- Non-wearable adult urine collection bag, open-ended FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 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: Non-wearable adult urine collection bag, open-ended
AMSure® Urinary Drainage Bag by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Non-wearable adult urine collection bag, open-ended.
- RUSCH — TELEFLEX INCORPORATED · Class II
- SteriGear — Sterigear, LLC · Class II
- MedPride — SHIELD-LINE, LLC · Class II
- Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 18" — UROCARE PRODUCTS, INC. · Class I
- Urocare® Tubing White-Rubber with Connector and Clamp 0.31" x 18" — UROCARE PRODUCTS, INC. · Class II
- Conveen Standard — Coloplast A/S · Class I
- Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60" — UROCARE PRODUCTS, INC. · Class I
- ASP MEDICAL — Asp Global, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (2)
- FDA UDI 139a0782-6d68-4823-a3ae-8404261b5764 34 fields · synced Oct 6, 2026
- EUDAMED 91885285-d834-4680-889b-eb1f405fe3b8 61 fields · synced Oct 5, 2026