Devices (same UDI-DI)
1
Certificates
1
Countries
4
Notified Bodies
1
Basic Information
- Primary DI
- 08809369092785
- Basic UDI-DI Code
- B-08809369092785
- Reference
- C8N
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- BNC KOREA, Inc.
Additional Description
This product consists of stabilized sodium hyaluronate generated by streptococcal bacteria and formulated to a concentration of 20 mg/mL, suspended in a physiological buffer. It is a transparent, viscous and sterile gel, supplied in a disposable pre-filled syringe. The syringe is equipped with a plunger, a plunger rod and a finger grip. It has one syringe and two needles in a blister pack.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P900402 | RESORBABLE FILLING AND RECONSTRUCTION DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2017-MDD/QS-044/C, 2017-MDD/DE-045/C | 3EC International a.s. | Expired |
Available In Countries
🇨🇾 Cyprus
🇩🇪 Germany
🇸🇪 Sweden
🇹🇷 Türkiye
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