Identity
- Trade Name
- Tealmed FDA UDI
- Generic Name
- First aid limb splint, mouldable, single-use FDA UDI
- Model / Reference
- #IS-5209 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974546525126 FDA UDI
- FDA Product Code
- ILH FDA UDI
- GMDN Term
- First aid limb splint, mouldable, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: First aid limb splint, mouldable, single-use
Tealmed by Ningbo Tealmed Emergency Products Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as First aid limb splint, mouldable, single-use.
- Redi Splint — FARETEC, INC. · Class I
- Lightning X Products, Inc — Wuxi Emsrun Technology Co., Ltd. · Class I
- MedSource Air Splint Set — MEDSOURCE INTERNATIONAL LLC · Class I
- EMSRUN — Wuxi Emsrun Technology Co., Ltd. · Class I
- Redicare — REDICARE LLC · Class I
- Redi Splint — FARETEC, INC. · Class I
- Redi Splint — FARETEC, INC. · Class I
- Prometheus Omni Splint Flat — SAFEGUARD MEDICAL TECHNOLOGIES LIMITED · 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 |
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Manufacturer
- Manufacturer
- Ningbo Tealmed Emergency Products Co., Ltd.
Sources (1)
- FDA UDI ae5f27be-756b-4105-b692-1395f43384fe 32 fields · synced May 30, 2026