Accu-Chek Spirit Combo
Basic Information
- Primary DI
- 04015630078516
- Basic UDI-DI Code
- B-04015630078516
- Reference
- 08433232001
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Roche Diabetes Care GmbH
Additional Description
Accu-Chek Combo Kit Light mmol A-FI/fi components are: 05027250001 Accu-Chek Spirit Combo Portable, battery-operated insulin pump for use with a remote control (as an accessory) for continuous subcutaneous infusion of insulin U100, or for continuous intraperitoneal infusion of insulin U100 in combination with the Accu-Chek" DiaPort System, with variable basal rates for use with 3.15 ml glass or plastic cartridges. and 05075718005 Accu-Chek Aviva Combo, blood-glucose monitoring system and 07531656001 Accu-Chek FastClix Lancing Device and 06436072001 Accu-Chek Fastclix (6 Lancets): Accu-Chek FastClix is a system intended for the collection of capillary blood for diagnostic purposes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z120402160102 | PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 092547 0014 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).