Eu Aimdd
Eu Aimdd Class
On The Market
🇺🇸 United States
remede System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00857688007001
- Basic UDI-DI Code
- B-00857688007001
- Reference
- 1001
- Device Types
-
Single use Sterile
- Regulation
- Eu Aimdd
- Classification
- Eu Aimdd Class
- Status
- On The Market
- Manufacturer
- ZOLL Respicardia, Inc.
Additional Description
The remedē® System is an implantable phrenic nerve stimulator indicated for the treatment of central sleep apnea (CSA) in adult patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| J0206 | FRENIC NERVE IMPLANTABLE NEUROSTIMULATORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| AIMDD Annex II Section 4 | 559663 | BSI Group The Netherlands B.V. | Expired |
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