VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Basic Information
- Primary DI
- 08800033900108
- Basic UDI-DI Code
- B-08800033900108
- Reference
- UBS-TCF-01-01
- Device Types
-
Single use
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Ubiosis
Additional Description
COLTRIX® CartiRegen, Collaju® is a collagen-based tissue supplement to promote bone or cartilage regeneration when used in conjunction with the bone marrow stimulation (BMS) technique—microfracture or drilling to create tiny fractures for the repair of damaged articular cartilage acting as support for bone marrow-derived cells. It is non-immunogenic pure collagen derived from porcine skin filtered with 0.2㎛ membrane and pre-filled in a 1 mL syringe supplied with 2 of 18G needles. This product is available as sterile condition (Aseptic filtration) to the market and it is recommended to store at room temperature(1~30℃) avoid direct sunlight
CND Nomenclature Codes
| Code | Description |
|---|---|
| V9099 | VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2019-MDD/QS-020/A | 3EC International a.s. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).