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Wearever
EUDAMEDFDA UDIClass I (EU MDR)
Ref MBB300-GRY-1X-EAModel MBB300Ref L100BGE2XLModel L100Ref L109WHTSMModel L109Ref L100WHTLGRef HDL200BGE4XLModel HDL200Ref L17BGE3XModel L17Ref MBB100NAV3XModel MBB100
Identity
- Trade Name
- Wearever EUDAMEDFDA UDI
- Generic Name
- Incontinence pants, reusable FDA UDI
- Device Name
- Wearever Men's Trunk Boxer Brief EUDAMEDWashable Reusable Men's Incontinence Trunk Boxer, GRY, 1X FDA UDI
- Model / Reference
- MBB300 EUDAMEDMBB300-GRY-1X-EA EUDAMEDFDA UDIL100 EUDAMEDL100BGE2XL EUDAMEDL109 EUDAMEDL109WHTSM EUDAMEDL100WHTLG EUDAMEDHDL200 EUDAMEDHDL200BGE4XL EUDAMEDL17 EUDAMEDL17BGE3X EUDAMEDMBB100 EUDAMEDMBB100NAV3X EUDAMED
- Description
- Washable Reusable Men's Incontinence Trunk Boxer, GRY, 1X FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810065845092 EUDAMEDFDA UDI00899624001568 EUDAMED00899624001353 EUDAMED00899624001490 EUDAMED00813877013550 EUDAMED00813877019194 EUDAMED00813877011617 EUDAMED
- Basic UDI-DI
- 081006584MBB300R4 EUDAMED0899624001L100ZL EUDAMED0899624001L10929 EUDAMED081387701HDL200YZ EUDAMED081387701L17DF EUDAMED081387701MBB100XZ EUDAMED
- Direct Marketing DI
- 00810065845092 EUDAMED00899624001568 EUDAMED00899624001353 EUDAMED00899624001490 EUDAMED00813877013550 EUDAMED00813877019194 EUDAMED00813877011617 EUDAMED
- FDA Product Code
- EYQ FDA UDI
- EMDN Code
- T04010104 NET PANTS EUDAMEDT04010102 SHAPED INCONTINENCE NAPPIES EUDAMED
- GMDN Term
- Incontinence pants, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5920 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Wearever by Prime Life Fibers Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081006584MBB300R4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Prime Life Fibers Inc.
- EUDAMED SRN
- US-MF-000014613
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (8)
- EUDAMED dda9094e-171d-4c81-877a-83421e5f836f 61 fields · synced Sep 30, 2026
- FDA UDI 0199c7e9-b2b4-4e40-b1bc-e61e1b9d1c31 33 fields · synced May 30, 2026
- EUDAMED 9cbfa2c4-fbdf-470d-9e81-9eb63f558639 61 fields · synced Jul 8, 2026
- EUDAMED 0f6555ea-ac92-46aa-a6e3-6559a325742a 61 fields · synced Jul 8, 2026
- EUDAMED f45f25f4-9462-49b7-ab60-3726769b3fc5 61 fields · synced Jul 8, 2026
- EUDAMED 5baab2cb-bc90-46c2-b83f-db7486a43601 61 fields · synced Jul 8, 2026
- EUDAMED ad270fe9-e110-4b91-8c85-4634c0a2431d 61 fields · synced Aug 1, 2026
- EUDAMED f5dfd138-c20d-4d20-a16a-dbc2d984f307 61 fields · synced Aug 1, 2026