TCM 4 Series ETX Base Unit
Catalogue number 391-880, listed by Radiometer Medical APS, Denmark, under Oximeter, Ear. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Sichuan (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Radiometer Medical APS, Denmark |
|---|---|
| FDA product code | DPZ |
| Device type | Oximeter, Ear |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2710 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2025-04-23 |
| Record revised | 2026-03-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -10 to 60 °C; Storage environment humidity 0 to 95 % RH |
| Distribution end date | 2025-10-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 391-880 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TruSignal SpO2 | GE Healthcare Finland OY | 16 |
| Oximeter, Ear | GE Healthcare Finland OY | 9 |
| Ear sensor | Honeywell Healthcare Solutions GmbH | 8 |
| BCI | ICU Medical, Inc | 3 |
| TruSignal SpO2 | GE Medical Systems, LLC | 2 |
| 103164 tCOM+ | Sentec AG | 1 |
| Multi-Site Attachment Ring for mature/intact skin | Sentec AG | 1 |
| Sentec Digital Monitor | Sentec AG | 1 |
| Contact Gel | Sentec AG | 1 |
| 103421 Sensor Adapter Cable (Long) | Sentec AG | 1 |
| Digital Sensor Adapter Cable, 250 cm | Sentec AG | 1 |
| Non-Adhesive Wrap | Sentec AG | 1 |
Showing 12 of 40. All products under Oximeter, Ear
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.