NON-ADHERENT ABSORBENT DRESSINGS
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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
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