Siemens
Siemens UNITY 2-NIPPLE KIT 2PCS FOR INSITU HEADSET
2manufacturers in China registered for this device type
57catalogue numbers in this listing
Who Else Makes It
All of them in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fastsound Acoustic Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Zoomax Technology Co., Limited | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | WS Audiology USA, Inc., United States |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-05-08 |
| Record revised | 2023-11-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2020-11-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UNITY 3 INSERTS (REFURBISHED) | Withdrawn | |
| UNITY 3 HIT UNIT – REWORKED | Withdrawn | |
| UNITY 3 HDA200 HEADSET | Withdrawn | |
| UNITY 3 EXTENSION CABLE | Withdrawn | |
| UNITY 3 FITTING UNIT | Withdrawn | |
| UNITY 2-CLIP HEADBAND FOR INSITU HEADSET | Withdrawn | |
| UNITY 3 HIT UNIT PACKAGE | Withdrawn | |
| UNITY 3 REAL EAR FULL PACKAGE | Withdrawn | |
| UNITY 3 SOFTWARE (USB STICK) | Withdrawn | |
| UNITY 2 USER MANUAL AUDIOMETRY | Withdrawn | |
| UNITY 3 STANDARD WITH INSERTS | Withdrawn | |
| UNITY 3 B71 BONE CONDUCTOR | Withdrawn | |
| UNITY 2 USB2.0 CABLE AUD KEYBOARD | Withdrawn | |
| UNITY 3 WITH INSERT | Withdrawn | |
| UNITY 3 REAL EAR FULL PACKAGE | Withdrawn | |
| UNITY 3 B71 BONE CONDUCTOR | Withdrawn | |
| UNITY 3 3A INSERTS | Withdrawn | |
| UNITY 2 AUDIOMETRY KEYBOARD PACKAGE | Withdrawn | |
| UNITY 2 CD CABLE 3M | Withdrawn | |
| UNITY 3 B71 (REFURBISHED) | Withdrawn | |
| UNITY 3 COUPLER (REFURBISHED) | Withdrawn | |
| UNITY 3 ER 3A (REFURBISHED) | Withdrawn | |
| UNITY 3 COUPLER MICROPHONE | Withdrawn | |
| UNITY 3 ITE PADDY | Withdrawn | |
| UNITY 2 AUDIOMETRY KEYBOARD | Withdrawn | |
| UNITY 3 STANDARD WITH INSERTS | Withdrawn | |
| UNITY 2 INSITU REM HEADSET CLAM | Withdrawn | |
| UNITY 2 INSITU HEADBAND SMALL | Withdrawn | |
| UNITY 3 ITE FOAM | Withdrawn | |
| UNITY 2 CONTROL UNIT DD45 | Withdrawn | |
| UNITY 3 HDA300 HEADSET | Withdrawn | |
| UNITY 3 QUICK INSTALLATION GUIDE | Withdrawn | |
| UNITY 2-IHM60 INSITU HEADSET KIT | Withdrawn | |
| UNITY 3 FITTING UNIT – REWORKED | Withdrawn | |
| UNITY 3 DD45 | Withdrawn | |
| UNITY 2 CONTROL UNIT WITHOUT CALIBRATION | Withdrawn | |
| UNITY 3 REFERENCE MICROPHONE | Withdrawn | |
| UNITY 3 REF MIC (REFURBISHED) | Withdrawn | |
| UNITY 3 WITH INSERTS | Withdrawn | |
| UNITY 3 REF MIC RECD AIR-FAT | Withdrawn | |
| UNITY 3 CLINICAL | Withdrawn | |
| Unity 3 Fitting Unit – Package | Withdrawn | |
| UNITY 3 STANDARD PACKAGE | Withdrawn | |
| UNITY 3 HIT UNIT | Withdrawn | |
| UNITY 2-GOOSE NECK KIT INSITU | Withdrawn | |
| UNITY 3 ACOUSTIC TEST UNIT | Withdrawn | |
| UNITY 3 CLINICAL | Withdrawn | |
| UNITY 3 HDA300 HEADSET | Withdrawn | |
| UNITY 3 DD45 (REFURBISHED) | Withdrawn | |
| UNITY 3 STANDARD | Withdrawn | |
| UNITY 2 TEST BOX | Withdrawn | |
| UNITY 2 – POWER SUPPLY 20V 100 | Withdrawn | |
| UNITY 3 BTE TUBE | Withdrawn | |
| UNITY 3 HIGH FREQUENCY | Withdrawn | |
| Unity 3 COUP. MIC RECD AIR-FAT | Withdrawn | |
| UNITY 2-NIPPLE KIT 2PCS FOR INSITU HEADSET | Withdrawn | |
| UNITY 3 HIGH FREQUENCY | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RadioEar A/S | Interacoustics A/S | 131 |
| GN Otometrics A/S | Natus Medical Denmark ApS | 88 |
| Audiometer | Etymotic Research, Inc. | 73 |
| Bio-logic | Natus Medical Incorporated | 33 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 29 |
| Real-EAR | WS Audiology USA, Inc. | 26 |
| Sanibel Supply A/S | Interacoustics A/S | 18 |
| Natus | Natus Medical Incorporated | 14 |
| Grason-Stadler | Diagnostic Group LLC | 12 |
| Interacoustics | Interacoustics A/S | 12 |
| Oscilla | Inmedico A/S | 12 |
| Single Use Eartip | Etymotic Research, Inc. | 12 |
Showing 12 of 348. All products under Audiometer
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.