Identity
- Trade Name
- Diagnostix™ FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
- Device Name
- Adstation Oto-Xen/Coax Oph-Xen, ,9003W/Spec Disp, WB, EU FDA UDI
- Model / Reference
- 5610X-38EUW FDA UDI
- Description
- Adstation Oto-Xen/Coax Oph-Xen, ,9003W/Spec Disp, WB, EU FDA UDI
Identifiers
- Catalog Number
- 5610X-38EUW FDA UDI
- Primary DI / UDI-DI
- 00634782097523 FDA UDI
- FDA Product Code
- DXN FDA UDIERA FDA UDIHLJ FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI874.4770 FDA UDI886.1570 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic/otologic diagnostic setAutomatic-inflation electronic sphygmomanometer, non-portable
Diagnostix™ by American Diagnostic Corporation — 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
- American Diagnostic Corporation
Sources (1)
- FDA UDI 80c5a49d-7f2e-47a9-b0a1-295a4cdff9f0 36 fields · synced Jun 8, 2026