FDA Registration
Active
🇺🇸 United States
A&D Engineering, Inc.
Reg #: 1054421
·
FEI: 1000110823
·
Expires 2026
Products
6
Proprietary Names
77
Establishment Types
3
Classifications
6
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Registration Details
- Registration Name
- A&D Engineering, Inc.
- Registration Number
- 1054421
- FEI Number
- 1000110823
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2605 N.Berkeley Lake Rd., Bldg 100, ste 350
- City
- Duluth
- State
- GA
- ZIP
- 30096
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173065
Owner / Operator
- Firm Name
- A&D Company, Limited
- Operator Number
- 8031633
- Address
- 3-23-14 HIGASHI-IKEBUKURO
- City
- TOSHIMA-KU
- State
- Tokyo
- Postal Code
- 170-0013
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-06-19 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2014-01-03 |
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2020-02-03 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2022-12-27 |
| Scale, Patient | FRW | Class 1 | General Hospital | No | 2005-09-09 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2023-10-12 |
Proprietary Names
TM-CF602D
TM-2440 & TM-2441
TM-CF702D
UltraConnect UA-1200BLE Blood Pressure Monitor
UA-1200CNBLE
UA-789AC
DT-102
DT-103
A&D Medical UM-211 Digital Blood Pressure Monitor
A&D Medical UB-543
UA-660
UA-651M-AC
UA-651W-AC
UA-651
UA-651S-AC
UA-651L-AC
UA-611
UA-660CN
UB-525
Digital Blood Pressure Monitor
DT-105 Thermometer
UltraConnect UB-1100BLE Blood Pressure Monitor
UA-767PVS
UA-767Plus
UA-787EJ
UA-787
UA-767PSAC
UA-1030T
UA-1020
UC-355PBT-Ci
UC-352BLE-V
UC-350BLE
UC-351
UC-352BLE
UC-321PBT-Q
UC-351PBT-Ci
UC-356BLE
UC-356BLE-ST
UM-SARS4K1KEC
UM-AURS2M1KEC
UM-SARS2M1KEC
UM-212BLE Blood Pressure Monitor
UM-AURS4K1KEC
UM-SSRS2M1KEC
UM-LLRS4K1KEC
UM-LARS4K1KEC
UM-LARS2M1KEC
UM-SSRS4K1KEC
UM-LLRS2M1KEC
UA-704
System, Measurement, Blood Pressure Non-invasive
UA-705
UA-705V
UA-705VL
UC-352CEL
UA-420
UA-767FAC
UA-767F
UA-4010WM
UA-651SAC
UA-651LAC
UA-651BLE
UM-WRRS2M1KEC
UA-651BLE-V
UA-651BLES-V
UA-651CEL-SM
UA-1020CEL
UA-810BLE
UA-372A
UA-1040TBLE
UA-910BLE
UA-770BLE
UA-6010BLEWM
UA-8010BLEWM
UA-1020CEL-CS
UC-450BLE-CV
UC-450BLE
Establishment Types
Remanufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198