Identity
- Trade Name
- Amico Diagnostic Rollstand FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- Diag. Station - Ophthal & Oto LED , Spec. Disp, Aneroid & Adlt Cuff, Roll Stand Adult 2-Piece Cuff, 2 Tubes LF, Navy Blue, Infl Bulb x Screw Female Connector (DI 00697077000769) Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) FDA UDI
- Model / Reference
- DS-UR1-CLFL-DAX FDA UDI
- Description
- Diag. Station - Ophthal & Oto LED , Spec. Disp, Aneroid & Adlt Cuff, Roll Stand Adult 2-Piece Cuff, 2 Tubes LF, Navy Blue, Infl Bulb x Screw Female Connector (DI 00697077000769) Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00697077001667 FDA UDI
- FDA Product Code
- HLI FDA UDIERA FDA UDIDXQ FDA UDI
- GMDN Term
- Aneroid manual sphygmomanometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 FDA UDI874.4770 FDA UDI870.1120 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Aneroid manual sphygmomanometerDirect ophthalmoscope
Amico Diagnostic Rollstand by Amico Diagnostic Incorporated — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Amico Diagnostic Incorporated
Sources (1)
- FDA UDI 6349e338-6893-4c75-a58d-d3a4a81678ec 34 fields · synced May 31, 2026