Urine Bag
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Wellead Urine Bag EUDAMEDUrine Bag FDA UDI
- Generic Name
- Wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Urine Bag-Drainage Bag EUDAMEDDrainage Bag (Type B) 2000ml T tap FDA UDI
- Model / Reference
- F04B042010 EUDAMEDFDA UDI2000ml+1200mm tubing，Cross valve，Sterile EUDAMED
- Description
- Drainage Bag (Type B) 2000ml T tap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881173981 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449327FF04A02EQ EUDAMED
- FDA Product Code
- KNX 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Market of Registration
- Germany 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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Wearable adult urine collection bag, open-ended
Urine Bag by Well Lead Medical Co., Ltd — Class II — MDR, 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
- Flexicare — FLEXICARE MEDICAL LIMITED · Class I
- 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
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Dover — Cardinal Health 200, LLC · Class I
- AMSure® Urinary Leg Bag — AMSINO INTERNATIONAL, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd
Sources (2)
- FDA UDI 9fad1177-5f4a-480d-997d-b447068970a6 33 fields · synced Oct 8, 2026
- EUDAMED 159aad19-b70e-46fd-a7e0-90ecc0d48d28 61 fields · synced Oct 7, 2026