Diagnostix™
by American Diagnostic Corporation United States EUDAMEDGUDID
Ref 700-11AN1
Product code DXQEMDN C9006
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00634782096212 | Date18 Apr 2023 | StatusActive |
| United States | GUDID listing GUDID | Number00634782096212 | Date29 Aug 2020 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Aneroid manual sphygmomanometer
- Device Name
- Aneroid Sphygmomanometer
- Model / Ref / Catalog
- 700-11AN1
- Primary DI / UDI-DI
- 00634782096212
- Basic UDI-DI
- B-00634782096212
- FDA Product Code
- DXQ
- EMDN Code
- C9006 Aneroid sphygmomanometers
- GMDN Term
- Aneroid manual sphygmomanometer
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 870.1120
- Market of Registration
- Romania
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000021544
- Authorised representative
- S.C. Cattus S.R.L. RO-AR-000020096
Other devices from American Diagnostic Corporation
Properties & raw data
Show properties, registry sources and raw records
Other properties (18)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
Sources (2)
- EUDAMED cf79ca4f-b083-4a47-a5a4-353f382c2c38
- FDA UDI e6d15806-f00c-485b-9337-afd261e95e99