FDA Registration
Active
🇩🇪 Germany
eResearchTechnology GmbH
Reg #: 3008505660
·
FEI: 3008505660
·
Expires 2026
Products
9
Proprietary Names
32
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- eResearchTechnology GmbH
- Registration Number
- 3008505660
- FEI Number
- 3008505660
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Sieboldstrasse 3
- City
- Estenfeld Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K091412
Owner / Operator
- Firm Name
- eResearch Technology
- Operator Number
- 10026366
- Address
- 1818 Market Street, Suite 2600
- City
- Philadelphia
- State
- PA
- Postal Code
- 19103
- Country
- US
- Correspondent
- Todd Kisner
US Agent
- Business Name
- ERESEARCH TECHNOLOGY
- Contact Name
- Todd Kisner
- Address
- 1818 Market Street, Suite 2600
- City
- Philadelphia
- State
- PA
- ZIP
- 19103
- Country
- US
- [email protected]
- Phone
- 609 9364594
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2011-01-07 |
| Plethysmograph, Volume | JEH | Class 2 | Anesthesiology | No | 2010-07-27 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2010-07-27 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2012-01-16 |
| Calculator, Predicted Values, Pulmonary Function | BTY | Class 2 | Anesthesiology | No | 2010-07-27 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2011-01-07 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2010-07-27 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2019-10-24 |
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2011-01-07 |
Proprietary Names
Clear Peak Flow Meter
Masterscreen PFT CT
Asthma Monitor
DIARYpro
My Data Uploader
ERT eCOA System
ERT ePRO System
ERT LogPad System
EXPERT, EXPERT ePRO, EXPERT Central, EXPERT Research and Integration Platform
Flowscreen
SpiroPro SP02
Flowscreen with ECG
Mouthpiece, 30 pieces
SpiroPro with BT & Sp02
Masterscreen IOS CT
SpiroSphere ECG
SpiroSphere
CardioSphere
AM1+/AM1+ BT
AM3/AM3 BT
CorScreen
Cor12+
Asthma Monitor AMOS App
Asthma Monitor AM3 G+
Masterscope ECG
SpiroPro
MasterScope WSSU
AM2/AM2+
iSpiro Ultrasonic Sensor
AM3 GSM
AM3 GSM/G+
AM3 BT+
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device