Identity
- Trade Name
- Sport Pediatric (2-10 Years) EUDAMEDSeal-Tight FDA UDI
- Generic Name
- Cast/bandage waterproof bathing cover, reusable FDA UDI
- Device Name
- SEAL-TIGHT® Sport Pediatric (2-10 Years) EUDAMEDCast and wound protector FDA UDI
- Model / Reference
- 20363 EUDAMEDFDA UDIArm EUDAMED
- Description
- Cast and wound protector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821612036368 EUDAMED00082161203636 FDA UDI
- Basic UDI-DI
- 082161STSPTPD210FC EUDAMED
- FDA Product Code
- KIA FDA UDI
- EMDN Code
- M03030299 PROTECTION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Cast/bandage waterproof bathing cover, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6185 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
No
FDA UDI
Category: Cast/bandage waterproof bathing cover, reusable
Seal-Tight by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cast/bandage waterproof bathing cover, reusable.
- LINEA GGDF 30 SILK HEEL COD. EU069 MIS. UNICA CONF. DA 3 PA ITA/ENG — EUMEDICA SRL · Class I
- cast padding — Anji Hengfeng Sanitary Material Co., Ltd · Class I
- Medical Compression Hosiery for Varices — Zhejiang Tuo zhen Medical Technology Co., Ltd. · Class I
- PLASTER OF PARIS BANDAGE — ANJI YAOHUI MEDICAL PRODUCTS CO., LTD. · Class I
- Transparent tape — Jiangsu Nanfang Medical Co., Ltd. · Class I
- Medical Compression Hosiery for Varices — Zhejiang Tuo zhen Medical Technology Co., Ltd. · Class I
- EMSRUN — Anji Hengfeng Sanitary Material Co., Ltd · Class I
- BIOS Living — Thermor Ltd · 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 bb49223d-3f7a-4601-855b-dceec776a8a6 33 fields · synced Aug 2, 2026
- EUDAMED d0e1c31a-5354-47b9-8b22-8dfbe2b7a4d4 61 fields · synced Aug 2, 2026