Eu Mdd
Eu Md Class 2a
On The Market
πΊπΈ United States
Healeon Duet
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 00850034511085
- Basic UDI-DI Code
- B-00850034511085
- Reference
- HM-DUET
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Bimini Health Tech
Additional Description
A device designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.
CND Nomenclature Codes
| Code | Description |
|---|---|
| B06 | CELLULAR OR BIOLOGICAL MANIPULATION DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | US19/819943606 | SGS Belgium NV | Expired |
Available In Countries
π«π· France
π³π± Netherlands
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