Identity
- Trade Name
- Abena FDA UDI
- Generic Name
- Adult nappy FDA UDI
- Device Name
- Abena Pants L1, Premium holds 47 fluid ounces/1400 ml, for individuals for waist and hip measurements of 39-55". Generally it is classified as a L size. FDA UDI
- Model / Reference
- 1000021325 FDA UDI
- Description
- Abena Pants L1, Premium holds 47 fluid ounces/1400 ml, for individuals for waist and hip measurements of 39-55". Generally it is classified as a L size. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713571000922 FDA UDI
- FDA Product Code
- EYQ FDA UDI
- GMDN Term
- Adult nappy FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Adult nappy
Abena by Abena North America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Adult nappy.
- Clever Choice — SIMPLE DIAGNOSTICS · Class I
- TENA — Essity Hygiene and Health AB · Class II
- FLUFSAN — EUROPROSAN SPA · Class I
- CUSTOMED — Customed, Inc. · Class I
- Topmed — Xiantao Topmed Nonwoven Protective Products Co., Ltd. · Class I
- Resilient Medical Solutions — Resilient Medical Solutions, LLC · Class I
- BrightCare Medsoft — THE GILBERT GROUP LLC · Class I
- FLUFSAN — EUROPROSAN SPA · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Abena North America, Inc.
Sources (1)
- FDA UDI 31673454-2c16-4421-a772-cf5e2c0db9c9 36 fields · synced May 30, 2026