Eu Mdd
Eu Md Class 3
On The Market
๐จ๐ณ China
NON-ADHERENT ABSORBENT DRESSINGS
Devices (same UDI-DI)
1
Certificates
3
Countries
12
Notified Bodies
3
Basic Information
- Primary DI
- 06952181201902
- Basic UDI-DI Code
- B-06952181201902
- Reference
- 40-012-010
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- BioRegen Biomedical (Changzhou) Co., Ltd.
Additional Description
HyaRegen Gel Pack include Absorbable Adhesion Barrier Gel (product proprietary name: HyaRegen Gel) and Injection Cannula. HyaRegen Gel is indicated for the prevention or reduction post-surgical adhesion formation in the abdomino-pelvic area after laparoscopic/hysteroscopic and open gynaecological surgical procedures. Injection Cannula is indicated for the delivery of the Gel. It is connected to the package (prefilled syringe) of the Gel and applies the Gel to the operative sites.
CND Nomenclature Codes
| Code | Description |
|---|---|
| M040204 | NON-ADHERENT ABSORBENT DRESSINGS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G10703400007 | TรV SรD Product Service GmbH | Expired |
| MDD Annex II Section 4 | G70703400009 | TรV SรD Product Service GmbH | Expired |
| MDD Annex V | G20703400010 | TรV SรD Product Service GmbH | Expired |
Available In Countries
๐ง๐ช Belgium
๐จ๐พ Cyprus
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
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