Mesoheal Bio
by Koru Pharma Co., Ltd EUDAMED
Active
Ref MBAD
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88002066MBAD | Date14 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Mesoheal Bio
- Model / Reference
- MBAD
- Primary DI / UDI-DI
- 08800206600330
- Basic UDI-DI
- 88002066MBAD
- EMDN Code
- M04040501 Hydrogel dressings, non-combined
- Device Class
- Class I
- Market of Registration
- Croatia
Manufacturer details
- EUDAMED SRN
- KR-MF-000037958
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Koru Pharma Co., Ltd
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No