Mepitel One - Indonesia BPOM Medical Device Registration
Mepitel One is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603027124. The device is manufactured by MöLNLYCKE HEALTH CARE AB from Sweden, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MEDI KHARISMA INTERNATIONAL.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
MöLNLYCKE HEALTH CARE ABCountry of Origin
Sweden
Authorized Representative
PT. MEDI KHARISMA INTERNATIONALAR Address
Jl. Darmo kali No.76, RT. 13/RW. 14 Kelurahan Darmo
Registration Date
Sep 02, 2022
Expiry Date
Jun 12, 2027
Product Type
Surgical Equipment
Occlusive Wound Dressing
Non Electromedic Sterile
MEPILEX Border Post-Op
MEPIFORM
EXUFIBER AT +
TUBIFAST
MEPILEX Border Sacrum
MEPILEX Border Sacrum Ag
MEPILEX XT
MEPILEX Border Post-Op
MEPILEX Foam Dressing
MEPILEX Border Ag
SDC Disposable Jet Wound Cleansing Set
WUHAN SDC MEDICAL TECHNOLOGY CO., LTD.
HYRUAN ONE Intra Articular Hyaluronic Acid
LG CHEM, LTD.
SDC Multifunctional Wound Debridement Instrument
WUHAN SDC MEDICAL TECHNOLOGY CO., LTD.
MEPILEX Border Post-Op
MöLNLYCKE HEALTH CARE AB
ZILFIX IV
HONY MEDICAL CO., LTD.
ZILTAPE PT Paper Tape
SHANGHAI CAREUS MEDICAL PRODUCT CO., LTD.
STERILIFE Nonwoven Fabric Wrap
STERIVIC MEDICAL CO., LTD.
MEPIFORM
MöLNLYCKE HEALTH CARE AB
STERILIFE Sterilization Gusseted Roll
STERIVIC MEDICAL CO., LTD.
STERILIFE Sterilization Flat Roll
STERIVIC MEDICAL CO., LTD.

