Eclipse Pro
Eclipse Pro,defib CABLE,PX,3 Snap,medium,ukca
4manufacturers in China registered for this device type
25catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| DM Systems (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Spacelabs Healthcare (Washington), Inc |
|---|---|
| FDA product code | MWJ |
| Device type | Electrocardiograph, Ambulatory (Without Analysis) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Record published | 2025-10-09 |
| Record revised | 2026-04-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution | |
| Eclipse Pro | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 60 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 58 |
| Norav NR Series | Norav Medical Inc. | 56 |
| Seer 1000 | Getemed Medizin- UND Informationstechnik AG | 15 |
| Seer 1000 ECG Cable | Getemed Medizin- UND Informationstechnik AG | 12 |
| ECG Cable for Seer 1000 | Getemed Medizin- UND Informationstechnik AG | 12 |
| Seer | Suzuken Co., Ltd. | 12 |
| H12+ | Mortara Instrument, Inc. | 10 |
| Lifecard | Spacelabs Healthcare (Washington), Inc | 10 |
| H3+ Patient Cable | Mortara Instrument, Inc. | 10 |
| Spiderview | Microport CRM SRL | 9 |
| ECG Cable for CM 3000-12 BT / Seer 12 | Getemed Medizin- UND Informationstechnik AG | 7 |
Showing 12 of 107. All products under Electrocardiograph, Ambulatory (Without Analysis)
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Spacelabs Healthcare Ltd. | UDI-DI | 2024-11-25 | Class II | Process control | Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device. | 13,202 devices |
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.