Identity
- Trade Name
- Leukoplast® EUDAMEDFDA UDI
- Generic Name
- Skin-cover adhesive strip, non-antimicrobial FDA UDI
- Device Name
- Leukoplast® strong EUDAMEDLEUKOPLAST STRONG 19X56MM TAN 10 NORDIC FDA UDI
- Model / Reference
- 76459-13 EUDAMEDFDA UDI
- Description
- LEUKOPLAST STRONG 19X56MM TAN 10 NORDIC FDA UDI
Identifiers
- Catalog Number
- 76459-13 FDA UDI
- Primary DI / UDI-DI
- 04042809666144 EUDAMEDFDA UDI
- Basic UDI-DI
- 4042809400342438F EUDAMED
- Unit of Use DI
- 04042809666151 EUDAMED
- FDA Product Code
- NAD FDA UDI
- EMDN Code
- M04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER EUDAMED
- GMDN Term
- Skin-cover adhesive strip, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4020 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 1.9 Centimeter FDA UDILength — 5.6 Centimeter FDA UDI
Category: Skin-cover adhesive strip, non-antimicrobial
Leukoplast® by Bsn Medical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bsn Medical, Inc.
Sources (2)
- FDA UDI b881ccc5-3118-401a-8d5f-859ec5e900fd 36 fields · synced Oct 11, 2026
- EUDAMED 36555895-63a1-4e82-b2ea-769d7fbdc4fd 61 fields · synced Oct 10, 2026