Auditdata A/S
3 inspections · 1 clearances · aggregated across 3 source records
Scorecard
Events per device across the 60-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0 →
0 in the last 12 months
Higher volume than 83% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
60 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| 2000 PRIMUS AUDIOMETER UNIT ICE (BASE UNIT) | 0 | |||
| 2000 PRIMUS FITTING UNIT PRO (BASE UNIT) | 0 | |||
| 2000 PRIMUS HIT UNIT | 0 | |||
| 2000-1 FITTING UNIT | 0 | |||
| 3000 Real Ear | SA1 RE-7 Headphone | EWO | 05711781004174 | 0 |
| 3000 Real Ear | IN1 Insert Earphone | EWO | 05711781004136 | 0 |
| 3000 Real Ear | CA1 HF Audiometric Headphone | EWO | 05711781004150 | 0 |
| 3000 Real Ear | BC1 Bone Conductor | EWO | 05711781004143 | 0 |
| 3000 Real Ear | SA1 HBA Headphone | EWO | 05711781004167 | 0 |
| 3000 Real Ear | CA1 Audiometric Headphone | EWO | 05711781004105 | 0 |
| Amplitude By Auditdata | Amplitude T3 | EWO | 05711781001661 | 0 |
| Amplitude By Auditdata | Amplitude T4 | EWO | 05711781001678 | 0 |
| Entomed By Auditdata | SA 201 (English) | EWO | 05711781001227 | 0 |
| Entomed By Auditdata | SA 204 (Spanish) | EWO | 05711781001401 | 0 |
| Entomed By Auditdata | SA 202 (Spanish) | EWO | 05711781001302 | 0 |
| Entomed By Auditdata | SA 201 (Spanish) | EWO | 05711781001289 | 0 |
| Entomed By Auditdata | SA 204 (English) | EWO | 05711781001258 | 0 |
| Entomed By Auditdata | SA 203 (English) | EWO | 05711781001241 | 0 |
| Entomed By Auditdata | SA 202 (English) | EWO | 05711781001234 | 0 |
| Entomed By Auditdata | SA 203 (Spanish) | EWO | 05711781001395 | 0 |
| Measure | Measure Software (USB stick) | EWO | 05711781002743 | 0 |
| Measure by Otometrics | AUD Base Package | EWO | 05711781004204 | 0 |
| Measure by Otometrics | AUD & REM & Speech Mapping Package | EWO | 05711781004235 | 0 |
| Measure by Otometrics | US/CA AUD Base (ANSI) Package | EWO | 05711781004280 | 0 |
| Measure by Otometrics | US/CA AUD & REM & Speech Mapping (ANSI) Package | EWO | 05711781004259 | 0 |
| Measure by Otometrics | AUD-HF & Wireless REM & Speech Mapping Package | EWO | 05711781004228 | 0 |
| Measure by Otometrics | AUD-HF & REM & Speech Mapping Package | EWO | 05711781004211 | 0 |
| Measure by Otometrics | US/CA AUD & Wireless REM & Speech Mapping (ANSI) Package | EWO | 05711781004266 | 0 |
| Measure by Otometrics | AUD & Wireless REM & Speech Mapping Package | EWO | 05711781004242 | 0 |
| Measure by Otometrics - HIT | HIT Pro Package | ETW | 05711781004297 | 0 |
Showing 1–30 of 60Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3008386587 | Auditdata A/S | Copenhagen Hovedstaden, DK | — | |
| 3004052117 | Auditdata, LLC | Pottstown, PA, US | NAI | |
| 3013596041 | Inission Syd AB (Malmo AB) | Malmo Skane, SE | — | |
| 3030089857 | Nordes Sp. z o.o. | Wroclaw Dolnoslaskie, PL | — |