Eu Mdd Eu Md Class 3 On The Market ๐Ÿ‡จ๐Ÿ‡ณ China

NON-ADHERENT ABSORBENT DRESSINGS

BioRegen Biomedical (Changzhou) Co., Ltd. ยท ๐Ÿ‡จ๐Ÿ‡ณ China
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

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
MDD Annex II (excluding section 4) G10703400007
MDD Annex II Section 4 G70703400009
MDD Annex V G20703400010

Available In Countries

๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

Similar Devices

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).

View all