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Basic Information
- Primary DI
- 08809639784808
- Basic UDI-DI Code
- B-08809639784808
- Reference
- BPLN-60JC
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- BioPlus Co., Ltd.
Additional Description
HELENE ALL consists of stabilized, hyaluronic acid (HA) formulated to a concentration of 2%(20mg/1ml). Hyaluronic acid based dermal filler composed of small particles intended for facial tissue augmentation by injection into skin layer. HELENE ALL is a transparent, viscous and sterile gel, supplied in a disposable pre- filled syringe. The contents of the syringe are sterile. The syringe is equipped with a plunger stopper, finger grip and plunger rod. Needles are on the outside of the blister package, and they are placed in a sterile condition in the packaging box.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P900402 | RESORBABLE FILLING AND RECONSTRUCTION DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 2195-MED-1418802 | Szutest Uygunluk Değerlendirme A.Ş. | Expired |
Available In Countries
Similar Devices
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