Identity
- Trade Name
- SMTube FDA UDI
- Generic Name
- Schirmer tear test strip FDA UDI
- Device Name
- Strip Meniscometry Tube, known as SMTube evaluates tear meniscus volume in 5 seconds. Catalog Number SMT14 is made for FDA compliance packaging for US Market. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Strip Meniscometry Tube, known as SMTube evaluates tear meniscus volume in 5 seconds. Catalog Number SMT14 is made for FDA compliance packaging for US Market. FDA UDI
Identifiers
- Catalog Number
- SMT14 FDA UDI
- Primary DI / UDI-DI
- 14582495170145 FDA UDI
- FDA Product Code
- KYD FDA UDI
- GMDN Term
- Schirmer tear test strip FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Schirmer tear test strip
SMTube by Echo Electricity Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Echo Electricity Co., Ltd.
Sources (1)
- FDA UDI 54d9601c-f76e-424b-a59d-f68e0abaa09c 34 fields · synced May 31, 2026