Identity
- Trade Name
- Shield EUDAMEDSeal Tight FDA UDI
- Generic Name
- Waterproof skin adhesive tape FDA UDI
- Device Name
- SEAL-TIGHT® Shield EUDAMEDCast and wound protector FDA UDI
- Model / Reference
- 20435 EUDAMEDFDA UDI5” x 8” EUDAMED
- Description
- Cast and wound protector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821612043502 EUDAMED00082161204350 FDA UDI
- Basic UDI-DI
- 082161STSHDC7 EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M03030299 PROTECTION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Waterproof skin adhesive tape FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 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
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
No
FDA UDI
Category: Waterproof skin adhesive tape
Seal Tight by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Waterproof skin adhesive tape.
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- ZINO — Kosma-Kare Canada Inc · Class I
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
- Brownmed, Inc.
Sources (2)
- FDA UDI 268ec7b4-701f-48ce-b0c7-f814900ab5c5 33 fields · synced Jun 18, 2026
- EUDAMED 54cfc3ac-fb10-42d5-8b01-2411082e2683 61 fields · synced Jun 18, 2026