Identity
- Trade Name
- UR-X FDA UDI
- Generic Name
- Medical video image recorder FDA UDI
- Model / Reference
- 1921067051 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04907034602117 FDA UDI
- FDA Product Code
- LMB FDA UDI
- GMDN Term
- Medical video image recorder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.2010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical video image recorder
Ur-X by Teac Manufacturing Solutions Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical video image recorder.
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- UR-4MD — Dongguan Teac Electronics Co., Ltd. · Class I
- MDR Video Touch — HYLAND LLC · Class II
- UR-4MD — Dongguan Teac Electronics Co., Ltd. · Class I
- MediCap — MEDICAPTURE, INC. · Class I
- CuratOR — EIZO CORPORATION · 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
- Teac Manufacturing Solutions Corporation
Sources (1)
- FDA UDI c3ef27b5-a28a-48d2-9bca-a1ce7392c7c9 32 fields · synced Jun 8, 2026