D-mine Pen Set
Basic Information
- Primary DI
- D-641xxST
- Basic UDI-DI Code
- B-641xxST
- Reference
- 641xx
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- EVER Neuro Pharma GmbH
Additional Description
The EVER Pharma D-mineยฎ Pen is a medical device for safe and reliable subcutaneous delivery of the drug apomorphine for the treatment of Parkinson's disease. The Pen delivers the liquid drug from a cartridge into the subcutaneous tissue. The Pen consists of the following parts: Cartridge Sleeve, Pen Cap with Clip, Scale Drum, Pen Mechanics and a metal Housing. The cartridge (3ml) will be inserted into the reusable Pen device. With a disposable pen needle the Pen is ready to deliver the drug by selecting the right dose with a variable dosing scale. The device has an automatic delivery (constant-spring driven) for lowest possible injection force. The device can deliver individual intermittent bolus injections on demand.
CND Nomenclature Codes
| Code | Description |
|---|---|
| A020203 | CARTRIDGE SYRINGES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 44232160652 | TรV NORD CERT GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).